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Clinical Trial Results:
A randomized, placebo-controlled, double-blind, parallel group, multicenter study to investigate the efficacy and safety of 5 fixed doses of BAY 85- 3934 administered orally in the correction of anemia in pre-dialysis subjects with chronic kidney disease not currently treated with erythropoiesis-stimulating agent in Europe and Asia Pacific

Summary
EudraCT number	2013-001193-14
Trial protocol	DE IT HU BG ES PL
Global end of trial date	23 Sep 2015

Results information
Results version number	v1(current)
This version publication date	30 Sep 2016
First version publication date	30 Sep 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

BAY85-3934/15141

ISRCTN number

US NCT number

NCT02021370

WHO universal trial number (UTN)

Sponsor organisation name

Bayer AG

Sponsor organisation address

Kaiser-Wilhelm-Allee, D-51368 Leverkusen, Germany,

Public contact

Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com

Scientific contact

Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

23 Sep 2015

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

23 Sep 2015

Was the trial ended prematurely?

Main objective of the trial

To evaluate the efficacy for up to 16 weeks of fixed dose treatment with BAY85-3934 versus placebo as measured by haemoglobin (Hb) levels.

Protection of trial subjects

The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.

Background therapy

Evidence for comparator

Actual start date of recruitment

10 Feb 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Bulgaria: 12

Country: Number of subjects enrolled

France: 1

Country: Number of subjects enrolled

Australia: 1

Country: Number of subjects enrolled

Germany: 5

Country: Number of subjects enrolled

Hungary: 10

Country: Number of subjects enrolled

Israel: 2

Country: Number of subjects enrolled

Italy: 18

Country: Number of subjects enrolled

Japan: 23

Country: Number of subjects enrolled

Korea, Democratic People's Republic of: 20

Country: Number of subjects enrolled

Poland: 11

Country: Number of subjects enrolled

Romania: 11

Country: Number of subjects enrolled

Spain: 2

Country: Number of subjects enrolled

United Kingdom: 5

Worldwide total number of subjects

121

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted at 53 active centers, enrolled subjects in 13 countries: Australia, Bulgaria, France, Germany, Hungary, Israel, Italy, Japan, Korea, Poland, Romania, Spain, and UK between 10 February 2014 (first subject first visit) and 23 September 2015 (last subject last visit).

Screening details

Of 210 subjects who were screened, 121 were randomised and treated and 89 subjects were not randomised. Of the treated subjects, 30 entered follow-up period and 87 subjects entered an extension study. Though all arms in follow-up period were mutually exclusive, in the respective section it is ticked "No" due to database validation rule constraints.

Period 1 title

Treatment period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Molidustat (BAY85-3934) 25 mg Once Daily

Arm description

Subjects received orally 1 tablet of Molidustat (BAY85-3934) 25 milligram (mg) along with 2 tablets of matching placebo in the morning, and approximately 12 hours apart received 3 tablets of matching placebo in the evening daily for 16 weeks.

Arm type

Experimental

Investigational medicinal product name

Molidustat

Investigational medicinal product code

BAY85-3934

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 1 tablet of Molidustat (BAY85-3934) 25 mg in the morning daily for 16 weeks.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 2 tablets of matching placebo in the morning, and approximately 12 hours apart received 3 tablets of matching placebo in the evening daily for 16 weeks.

Molidustat (BAY85-3934) 50 mg Once Daily

Arm description

Subjects received orally 2 tablets of Molidustat (BAY85-3934) (2 * 25 mg) along with 1 tablet of matching placebo in the morning, and approximately 12 hours apart received 3 tablets of matching placebo in the evening daily for 16 weeks.

Arm type

Experimental

Investigational medicinal product name

Molidustat

Investigational medicinal product code

BAY85-3934

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 2 tablets of Molidustat (BAY85-3934) (2 * 25 mg) in the morning daily for 16 weeks.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 1 tablet of matching placebo in the morning, and approximately 12 hours apart received 3 tablets of matching placebo in the evening daily for 16 weeks.

Molidustat (BAY85-3934) 75 mg Once Daily

Arm description

Subjects received orally 3 tablets of Molidustat (BAY85-3934) (3 * 25 mg) in the morning and with approximately 12 hours apart received 3 tablets of matching placebo in the evening daily for 16 weeks.

Arm type

Experimental

Investigational medicinal product name

Molidustat

Investigational medicinal product code

BAY85-3934

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 3 tablets of Molidustat (BAY85-3934) (3 * 25 mg) in the morning daily for 16 weeks.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 3 tablets of matching placebo in the evening daily for 16 weeks.

Molidustat (BAY85-3934) 25 mg Twice Daily

Arm description

Subjects received orally 1 tablet of Molidustat (BAY85-3934) 25 mg along with 2 tablets of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Arm type

Experimental

Investigational medicinal product name

Molidustat

Investigational medicinal product code

BAY85-3934

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 1 tablet of Molidustat (BAY85-3934) 25 mg in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 2 tablets of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Molidustat (BAY85-3934) 50 mg Twice Daily

Arm description

Subjects received orally 2 tablets of Molidustat (BAY85-3934) (2 * 25 mg) along with 1 tablet of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Arm type

Experimental

Investigational medicinal product name

Molidustat

Investigational medicinal product code

BAY85-3934

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 2 tablets of Molidustat (BAY85-3934) (2 * 25 mg) in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 1 tablet of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Placebo Twice Daily

Arm description

Subjects received orally 3 tablets of matching placebo to Molidustat (BAY85-3934) tablets orally in the morning and approximately 12 hours apart in the evening daily for 16 weeks.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 3 tablets of matching placebo to Molidustat (BAY85-3934) tablets in the morning and approximately 12 hours apart in the evening daily for 16 weeks.

Number of subjects in period 1	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Started	19	21	22	19	20	20
Completed	10	11	4	11	5	18
Not completed	9	10	18	8	15	2
Consent withdrawn by subject	-	1	-	-	-	-
Adverse event, non-fatal	3	-	3	2	1	-
Other	1	-	1	-	-	1
Protocol Violation	1	1	1	-	-	-
Protocol-driven decision point	4	8	13	5	14	1
Lost to follow-up	-	-	-	1	-	-

Period 2 title

Follow-up Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Molidustat (BAY85-3934) 25 mg Once Daily

Arm description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Arm type

Experimental

Investigational medicinal product name

Molidustat

Investigational medicinal product code

BAY85-3934

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 1 tablet of Molidustat (BAY85-3934) 25 mg in the morning daily for 16 weeks during treatment period.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 2 tablets of matching placebo in the morning, and approximately 12 hours apart received 3 tablets of matching placebo in the evening daily for 16 weeks during treatment period.

Molidustat (BAY85-3934) 50 mg Once Daily

Arm description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Arm type

Experimental

Investigational medicinal product name

Molidustat

Investigational medicinal product code

BAY85-3934

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 2 tablets of Molidustat (BAY85-3934) (2 * 25 mg) in the morning daily for 16 weeks during treatment period.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 1 tablet of matching placebo in the morning, and approximately 12 hours apart received 3 tablets of matching placebo in the evening daily for 16 weeks during treatment period.

Molidustat (BAY85-3934) 75 mg Once Daily

Arm description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Arm type

Experimental

Investigational medicinal product name

Molidustat

Investigational medicinal product code

BAY85-3934

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 3 tablets of Molidustat (BAY85-3934) (3 * 25 mg) in the morning daily for 16 weeks during treatment period.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 3 tablets of matching placebo in the evening daily for 16 weeks during treatment period.

Molidustat (BAY85-3934) 25 mg Twice Daily

Arm description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Arm type

Experimental

Investigational medicinal product name

Molidustat

Investigational medicinal product code

BAY85-3934

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 1 tablet of Molidustat (BAY85-3934) 25 mg in the morning, and approximately 12 hours apart in the evening daily for 16 weeks during treatment period.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 2 tablets of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks during treatment period.

Molidustat (BAY85-3934) 50 mg Twice Daily

Arm description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Arm type

Experimental

Investigational medicinal product name

Molidustat

Investigational medicinal product code

BAY85-3934

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 2 tablets of Molidustat (BAY85-3934) (2 * 25 mg) in the morning, and approximately 12 hours apart in the evening daily for 16 weeks during treatment period.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 1 tablet of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks during treatment period.

Placebo Twice Daily

Arm description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received orally 3 tablets of matching placebo to Molidustat (BAY85-3934) tablets in the morning and approximately 12 hours apart in the evening daily for 16 weeks during treatment period.

Number of subjects in period 2	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Started	5	5	7	8	3	2
Completed	4	3	7	5	3	1
Not completed	1	2	0	3	0	1
Consent withdrawn by subject	-	1	-	-	-	-
Adverse event, non-fatal	-	-	-	1	-	-
Other	-	-	-	1	-	1
Protocol Violation	-	1	-	-	-	-
Lost to follow-up	1	-	-	1	-	-

Baseline characteristics

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Reporting group title

Molidustat (BAY85-3934) 25 mg Once Daily

Reporting group description

Reporting group title

Molidustat (BAY85-3934) 50 mg Once Daily

Reporting group description

Reporting group title

Molidustat (BAY85-3934) 75 mg Once Daily

Reporting group description

Reporting group title

Molidustat (BAY85-3934) 25 mg Twice Daily

Reporting group description

Subjects received orally 1 tablet of Molidustat (BAY85-3934) 25 mg along with 2 tablets of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Reporting group title

Molidustat (BAY85-3934) 50 mg Twice Daily

Reporting group description

Subjects received orally 2 tablets of Molidustat (BAY85-3934) (2 * 25 mg) along with 1 tablet of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Reporting group title

Placebo Twice Daily

Reporting group description

Subjects received orally 3 tablets of matching placebo to Molidustat (BAY85-3934) tablets orally in the morning and approximately 12 hours apart in the evening daily for 16 weeks.

Reporting group values	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily	Total
Number of subjects	19	21	22	19	20	20	121
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	69.2 ( 12.09 )	68.2 ( 13.3 )	70.7 ( 9.7 )	69.8 ( 12.22 )	65.3 ( 12.84 )	67.1 ( 15.92 )	-
Gender categorical
Units: Subjects
Female	5	12	9	9	10	11	56
Male	14	9	13	10	10	9	65
Number of Japanese and Non-Japanese Subjects
Units: Subjects
Japanese Subjects	2	8	5	1	6	1	23
Non-Japanese Subjects	17	13	17	18	14	19	98
Estimated Glomerular Filtration Rate (eGFR)
eGFR is calculated using Modification of Diet in Renal Disease (MDRD) formula.
Units: milliliter/minute/1.73 square meter
arithmetic mean (standard deviation)	25.206 ( 14.0846 )	22.858 ( 11.5707 )	23.477 ( 10.0174 )	25.157 ( 11.8923 )	20.573 ( 14.2655 )	22.994 ( 11.5534 )	-
Local Laboratory Hemoglobin Levels
Units: gram/deciliter (g/dL)
arithmetic mean (standard deviation)	9.373 ( 0.6965 )	9.548 ( 0.6604 )	9.643 ( 0.6496 )	9.347 ( 0.4982 )	9.46 ( 1.0751 )	9.535 ( 0.6473 )	-
Erythropoietin
The number of subjects evaluated for Erythropoietin for the arms BAY85-3934 25 mg once daily, 50 mg once daily, 75 mg once daily, 25 mg twice daily, 50 mg twice daily, were n = 19,20,22,17,19,18 respectively.
Units: international units/liter
arithmetic mean (standard deviation)	20.327 ( 23.3699 )	12.476 ( 6.9364 )	12.194 ( 10.66 )	15.458 ( 15.5526 )	10.111 ( 4.6627 )	10.097 ( 5.8497 )	-
Reticulocyte Count
The number of subjects evaluated for Reticulocyte Count for the arms BAY85-3934 25 mg once daily, 50 mg once daily, 75 mg once daily, 25 mg twice daily, 50 mg twice daily, were n = 9,7,13,9,13,8 respectively.
Units: giga/liter
arithmetic mean (standard deviation)	77.8 ( 21.93 )	48.7 ( 19.41 )	65.1 ( 30.56 )	57.9 ( 19.68 )	60.2 ( 19.45 )	72.8 ( 22.35 )	-

End points

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Reporting group title

Molidustat (BAY85-3934) 25 mg Once Daily

Reporting group description

Reporting group title

Molidustat (BAY85-3934) 50 mg Once Daily

Reporting group description

Reporting group title

Molidustat (BAY85-3934) 75 mg Once Daily

Reporting group description

Reporting group title

Molidustat (BAY85-3934) 25 mg Twice Daily

Reporting group description

Subjects received orally 1 tablet of Molidustat (BAY85-3934) 25 mg along with 2 tablets of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Reporting group title

Molidustat (BAY85-3934) 50 mg Twice Daily

Reporting group description

Subjects received orally 2 tablets of Molidustat (BAY85-3934) (2 * 25 mg) along with 1 tablet of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Reporting group title

Placebo Twice Daily

Reporting group description

Subjects received orally 3 tablets of matching placebo to Molidustat (BAY85-3934) tablets orally in the morning and approximately 12 hours apart in the evening daily for 16 weeks.

Reporting group title

Molidustat (BAY85-3934) 25 mg Once Daily

Reporting group description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Reporting group title

Molidustat (BAY85-3934) 50 mg Once Daily

Reporting group description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Reporting group title

Molidustat (BAY85-3934) 75 mg Once Daily

Reporting group description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Reporting group title

Molidustat (BAY85-3934) 25 mg Twice Daily

Reporting group description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Reporting group title

Molidustat (BAY85-3934) 50 mg Twice Daily

Reporting group description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Reporting group title

Placebo Twice Daily

Reporting group description

Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

Subject analysis set title

Modified Intent-To-Treat set (mITT)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

mITT (N= 121) included all subjects randomized to study treatment, who received at least 1 dose of study treatment, and who had at least 1 post-baseline efficacy value available.

Subject analysis set title

Safety Analysis set (SAF)

Subject analysis set type

Safety analysis

Subject analysis set description

SAF (N= 121) included all randomized subjects who received at least 1 dose of study treatment.

Subject analysis set title

Pharmacodynamic set (PDS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

PDS (N= 121) included all subjects randomized with at least 1 available valid PD measurement.

Primary: Change in Local Laboratory Hemoglobin Level From Baseline to the Study Evaluation Period (Last 4 Weeks of Treatment Period)

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End point title

Change in Local Laboratory Hemoglobin Level From Baseline to the Study Evaluation Period (Last 4 Weeks of Treatment Period)

End point description

Study Evaluation Period (SEP) was defined as the last 4 planned weeks of the study treatment period. The values represented here are the average of all measurements taken during the last 4 weeks of the study treatment period.

End point type

Primary

End point timeframe

Baseline, Weeks 13 to 16

End point values	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Number of subjects analysed	12 ^[1]	11 ^[2]	5 ^[3]	13 ^[4]	9 ^[5]	19 ^[6]
Units: gram/deciliter (g/dL)
arithmetic mean (standard deviation)
Change at SEP	1.43 ( 1.115 )	1.42 ( 1.053 )	1.82 ( 0.701 )	1.66 ( 1.132 )	1.84 ( 1.192 )	0.17 ( 0.864 )

Notes
[1] - mITT with number of subjects evaluable for this end point.
[2] - mITT with number of subjects evaluable for this end point.
[3] - mITT with number of subjects evaluable for this end point.
[4] - mITT with number of subjects evaluable for this end point.
[5] - mITT with number of subjects evaluable for this end point.
[6] - mITT with number of subjects evaluable for this end point.

SEP: Analysis for Molidustat 25 mg Once Daily

Statistical analysis description

Results are reported including Least square mean (LS-mean) difference and 95 percent (%) confidence intervals (CI). LS mean difference was based on constrained longitudinal data analysis (cLDA) model including the response vector consisting of baseline and values at each post-baseline time point, and the repeated measures model including treatment, randomization stratification factors, time (visit), the interaction of time by treatment, and the interaction of time by randomization factors.

Comparison groups

Molidustat (BAY85-3934) 25 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[7]

Method

Parameter type

LS Mean Difference

Point estimate

1.22

Confidence interval

level

95%

sides

2-sided

lower limit

0.36

upper limit

2.08

Variability estimate

Standard error of the mean

Dispersion value

0.418

Notes
[7] - Analysis type involved here is exploratory.

SEP: Analysis for Molidustat 50 mg Once Daily

Statistical analysis description

Results are reported including LS-mean difference and 95 % CI. LS mean difference was based on cLDA model including the response vector consisting of baseline and values at each post-baseline time point, and the repeated measures model including treatment, randomization stratification factors, time (visit), the interaction of time by treatment, and the interaction of time by randomization factors.

Comparison groups

Molidustat (BAY85-3934) 50 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[8]

Method

Parameter type

LS Mean Difference

Point estimate

1.81

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

2.63

Variability estimate

Standard error of the mean

Dispersion value

0.397

Notes
[8] - Analysis type involved here is exploratory.

SEP: Analysis for Molidustat 75 mg Once Daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 75 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[9]

Method

Parameter type

LS Mean Difference

Point estimate

2.22

Confidence interval

level

95%

sides

2-sided

lower limit

1.29

upper limit

3.16

Variability estimate

Standard error of the mean

Dispersion value

0.447

Notes
[9] - Analysis type involved here is exploratory.

SEP: Analysis for Molidustat 25 mg Twice Daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[10]

Method

Parameter type

LS Mean Difference

Point estimate

1.72

Confidence interval

level

95%

sides

2-sided

lower limit

0.97

upper limit

2.47

Variability estimate

Standard error of the mean

Dispersion value

0.366

Notes
[10] - Analysis type involved here is exploratory.

SEP: Analysis for Molidustat 50 mg Twice Daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[11]

Method

Parameter type

LS Mean Difference

Point estimate

2.31

Confidence interval

level

95%

sides

2-sided

lower limit

1.26

upper limit

3.37

Variability estimate

Standard error of the mean

Dispersion value

0.503

Notes
[11] - Analysis type involved here is exploratory.

Secondary: Change in Local Laboratory Hemoglobin Level From Baseline to Multiple Time Points in First 12 Weeks of Treatment Period

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End point title

Change in Local Laboratory Hemoglobin Level From Baseline to Multiple Time Points in First 12 Weeks of Treatment Period

End point description

Here ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 3, 5, 7, 9, 11

End point values	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Number of subjects analysed	19 ^[12]	21 ^[13]	22 ^[14]	19 ^[15]	20 ^[16]	20 ^[17]
Units: g/dL
arithmetic mean (standard deviation)
Change at Week 2 (n= 19,21,22,19,20,20)	0.35 ( 0.536 )	0.11 ( 0.454 )	0.28 ( 0.395 )	0.12 ( 0.547 )	0.47 ( 0.812 )	0.06 ( 0.491 )
Change at Week 3 (n= 19,20,22,18,20,19)	0.41 ( 0.619 )	0.44 ( 0.531 )	0.58 ( 0.553 )	0.53 ( 0.565 )	0.56 ( 0.716 )	0.08 ( 0.577 )
Change at Week 5 (n= 19,19,20,16,19,20)	0.49 ( 0.758 )	0.82 ( 0.809 )	1.26 ( 0.793 )	1.01 ( 0.588 )	1.26 ( 1.064 )	0.08 ( 0.568 )
Change at Week 7 (n= 16,13,16,16,15,20)	0.7 ( 0.676 )	0.95 ( 0.981 )	1.58 ( 0.938 )	1.24 ( 1.022 )	1.32 ( 0.873 )	-0.09 ( 0.71 )
Change at Week 9 (n= 16,13,13,14,12,19)	1.15 ( 0.938 )	1.1 ( 1.026 )	1.44 ( 1.056 )	1.3 ( 0.937 )	1.81 ( 1.054 )	0.05 ( 0.709 )
Change at Week 11 (n= 15,10,10,13,10,19)	1.28 ( 1.274 )	1.14 ( 0.864 )	1.67 ( 0.958 )	1.36 ( 0.788 )	1.96 ( 1.248 )	-0.03 ( 0.883 )

Notes
[12] - mITT
[13] - mITT
[14] - mITT
[15] - mITT
[16] - mITT
[17] - mITT

Week 2: Analysis for Molidustat 25 mg once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[18]

Method

Parameter type

LS Mean Difference

Point estimate

0.33

Confidence interval

level

95%

sides

2-sided

lower limit

0.01

upper limit

0.66

Variability estimate

Standard error of the mean

Dispersion value

0.16

Notes
[18] - Analysis type involved here is exploratory.

Week 2: Analysis for Molidustat 50 mg once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[19]

Method

Parameter type

LS Mean Difference

Point estimate

0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-0.25

upper limit

0.34

Variability estimate

Standard error of the mean

Dispersion value

0.146

Notes
[19] - Analysis type involved here is exploratory.

Week 2: Analysis for Molidustat 75 mg once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 75 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[20]

Method

Parameter type

LS Mean Difference

Point estimate

0.24

Confidence interval

level

95%

sides

2-sided

lower limit

-0.18

upper limit

0.65

Variability estimate

Standard error of the mean

Dispersion value

0.21

Notes
[20] - Analysis type involved here is exploratory.

Week 2: Analysis for Molidustat 25 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[21]

Method

Parameter type

LS Mean Difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.24

upper limit

0.44

Variability estimate

Standard error of the mean

Dispersion value

0.167

Notes
[21] - Analysis type involved here is exploratory.

Week 2: Analysis for Molidustat 50 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[22]

Method

Parameter type

LS Mean Difference

Point estimate

0.43

Confidence interval

level

95%

sides

2-sided

lower limit

-0.01

upper limit

0.86

Variability estimate

Standard error of the mean

Dispersion value

0.214

Notes
[22] - Analysis type involved here is exploratory.

Week 3: Analysis for Molidustat 25 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[23]

Method

Parameter type

LS Mean Difference

Point estimate

0.41

Confidence interval

level

95%

sides

2-sided

lower limit

0.02

upper limit

0.79

Variability estimate

Standard error of the mean

Dispersion value

0.191

Notes
[23] - Analysis type involved here is exploratory. Number of subjects in this analysis were 38. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 3: Analysis for Molidustat 50 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[24]

Method

Parameter type

LS Mean Difference

Point estimate

0.35

Confidence interval

level

95%

sides

2-sided

lower limit

-0.01

upper limit

0.7

Variability estimate

Standard error of the mean

Dispersion value

0.176

Notes
[24] - Analysis type involved here is exploratory. Number of subjects in this analysis were 39. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 3: Analysis for Molidustat 75 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 75 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[25]

Method

Parameter type

LS Mean Difference

Point estimate

0.56

Confidence interval

level

95%

sides

2-sided

lower limit

0.14

upper limit

0.97

Variability estimate

Standard error of the mean

Dispersion value

0.212

Notes
[25] - Analysis type involved here is exploratory. Number of subjects in this analysis were 41. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 3: Analysis for Molidustat 25 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[26]

Method

Parameter type

LS Mean Difference

Point estimate

0.51

Confidence interval

level

95%

sides

2-sided

lower limit

0.11

upper limit

0.91

Variability estimate

Standard error of the mean

Dispersion value

0.197

Notes
[26] - Analysis type involved here is exploratory. Number of subjects in this analysis were 37. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 3: Analysis for Molidustat 50 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[27]

Method

Parameter type

LS Mean Difference

Point estimate

0.54

Confidence interval

level

95%

sides

2-sided

lower limit

0.12

upper limit

0.95

Variability estimate

Standard error of the mean

Dispersion value

0.204

Notes
[27] - Analysis type involved here is exploratory. Number of subjects in this analysis were 39. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 5: Analysis for Molidustat 25 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[28]

Method

Parameter type

LS Mean Difference

Point estimate

0.46

Confidence interval

level

95%

sides

2-sided

lower limit

0.02

upper limit

0.89

Variability estimate

Standard error of the mean

Dispersion value

0.216

Notes
[28] - Analysis type involved here is exploratory. Number of subjects in this analysis were 39. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 5: Analysis for Molidustat 50 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[29]

Method

Parameter type

LS Mean Difference

Point estimate

0.78

Confidence interval

level

95%

sides

2-sided

lower limit

0.31

upper limit

1.25

Variability estimate

Standard error of the mean

Dispersion value

0.233

Notes
[29] - Analysis type involved here is exploratory. Number of subjects in this analysis were 39. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 5: Analysis for Molidustat 75 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 75 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[30]

Method

Parameter type

LS Mean Difference

Point estimate

1.22

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.64

Variability estimate

Standard error of the mean

Dispersion value

0.214

Notes
[30] - Analysis type involved here is exploratory. Number of subjects in this analysis were 40. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 5: Analysis for Molidustat 25 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[31]

Method

Parameter type

LS Mean Difference

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.59

upper limit

1.38

Variability estimate

Standard error of the mean

Dispersion value

0.195

Notes
[31] - Analysis type involved here is exploratory. Number of subjects in this analysis were 36. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 5: Analysis for Molidustat 50 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[32]

Method

Parameter type

LS Mean Difference

Point estimate

1.22

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

1.77

Variability estimate

Standard error of the mean

Dispersion value

0.271

Notes
[32] - Analysis type involved here is exploratory. Number of subjects in this analysis were 39. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 7: Analysis for Molidustat 25 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[33]

Method

Parameter type

LS Mean Difference

Point estimate

0.69

Confidence interval

level

95%

sides

2-sided

lower limit

0.18

upper limit

1.2

Variability estimate

Standard error of the mean

Dispersion value

0.251

Notes
[33] - Analysis type involved here is exploratory. Number of subjects in this analysis were 36. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 7: Analysis for Molidustat 50 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[34]

Method

Parameter type

LS Mean Difference

Point estimate

1.15

Confidence interval

level

95%

sides

2-sided

lower limit

0.55

upper limit

1.75

Variability estimate

Standard error of the mean

Dispersion value

0.296

Notes
[34] - Analysis type involved here is exploratory. Number of subjects in this analysis were 33. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 7: Analysis for Molidustat 75 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 75 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[35]

Method

Parameter type

LS Mean Difference

Point estimate

1.77

Confidence interval

level

95%

sides

2-sided

lower limit

1.33

upper limit

2.21

Variability estimate

Standard error of the mean

Dispersion value

0.223

Notes
[35] - Analysis type involved here is exploratory. Number of subjects in this analysis were 36. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 7: Analysis for Molidustat 25 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[36]

Method

Parameter type

LS Mean Difference

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.71

upper limit

1.89

Variability estimate

Standard error of the mean

Dispersion value

0.291

Notes
[36] - Analysis type involved here is exploratory. Number of subjects in this analysis were 36. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 7: Analysis for Molidustat 50 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[37]

Method

Parameter type

LS Mean Difference

Point estimate

1.55

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

2.25

Variability estimate

Standard error of the mean

Dispersion value

0.34

Notes
[37] - Analysis type involved here is exploratory. Number of subjects in this analysis were 35. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 9: Analysis for Molidustat 25 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[38]

Method

Parameter type

LS Mean Difference

Point estimate

1.07

Confidence interval

level

95%

sides

2-sided

lower limit

0.46

upper limit

1.69

Variability estimate

Standard error of the mean

Dispersion value

0.302

Notes
[38] - Analysis type involved here is exploratory. Number of subjects in this analysis were 35. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 9: Analysis for Molidustat 50 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[39]

Method

Parameter type

LS Mean Difference

Point estimate

1.29

Confidence interval

level

95%

sides

2-sided

lower limit

0.65

upper limit

1.93

Variability estimate

Standard error of the mean

Dispersion value

0.315

Notes
[39] - Analysis type involved here is exploratory. Number of subjects in this analysis were 32. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 9: Analysis for Molidustat 75 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 75 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[40]

Method

Parameter type

LS Mean Difference

Point estimate

1.67

Confidence interval

level

95%

sides

2-sided

lower limit

1.2

upper limit

2.13

Variability estimate

Standard error of the mean

Dispersion value

0.235

Notes
[40] - Analysis type involved here is exploratory. Number of subjects in this analysis were 32. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 9: Analysis for Molidustat 25 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[41]

Method

Parameter type

LS Mean Difference

Point estimate

1.44

Confidence interval

level

95%

sides

2-sided

lower limit

0.83

upper limit

2.05

Variability estimate

Standard error of the mean

Dispersion value

0.299

Notes
[41] - Analysis type involved here is exploratory. Number of subjects in this analysis were 33. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 9: Analysis for Molidustat 50 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[42]

Method

Parameter type

LS Mean Difference

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

1.17

upper limit

2.64

Variability estimate

Standard error of the mean

Dispersion value

0.356

Notes
[42] - Analysis type involved here is exploratory. Number of subjects in this analysis were 31. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 11: Analysis for Molidustat 25 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[43]

Method

Parameter type

LS Mean Difference

Point estimate

1.33

Confidence interval

level

95%

sides

2-sided

lower limit

0.56

upper limit

2.11

Variability estimate

Standard error of the mean

Dispersion value

0.381

Notes
[43] - Analysis type involved here is exploratory. Number of subjects in this analysis were 34. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 11: Analysis for Molidustat 50 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[44]

Method

Parameter type

LS Mean Difference

Point estimate

1.62

Confidence interval

level

95%

sides

2-sided

lower limit

0.9

upper limit

2.34

Variability estimate

Standard error of the mean

Dispersion value

0.353

Notes
[44] - Analysis type involved here is exploratory. Number of subjects in this analysis were 29. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 11: Analysis for Molidustat 75 mg Once daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 75 mg Once Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[45]

Method

Parameter type

LS Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

1.51

upper limit

2.5

Variability estimate

Standard error of the mean

Dispersion value

0.25

Notes
[45] - Analysis type involved here is exploratory. Number of subjects in this analysis were 29. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 11: Analysis for Molidustat 25 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 25 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[46]

Method

Parameter type

LS Mean Difference

Point estimate

1.66

Confidence interval

level

95%

sides

2-sided

lower limit

1.04

upper limit

2.29

Variability estimate

Standard error of the mean

Dispersion value

0.306

Notes
[46] - Analysis type involved here is exploratory. Number of subjects in this analysis were 32. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Week 11: Analysis for Molidustat 50 mg Twice daily

Statistical analysis description

Comparison groups

Molidustat (BAY85-3934) 50 mg Twice Daily v Placebo Twice Daily

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[47]

Method

Parameter type

LS Mean Difference

Point estimate

2.48

Confidence interval

level

95%

sides

2-sided

lower limit

1.51

upper limit

3.45

Variability estimate

Standard error of the mean

Dispersion value

0.468

Notes
[47] - Analysis type involved here is exploratory. Number of subjects in this analysis were 29. The number of subjects mentioned in the above table is auto-generated which cannot be edited.

Secondary: Rate of Change in Hemoglobin Level Over Time

Top of page

End point title

Rate of Change in Hemoglobin Level Over Time

End point description

Rate of change is defined as change in Hb values divided by duration between two Hb values (involved in the calculation of the change). Here, n indicates the number of subjects evaluable for this measure at specified time points for each arm group respectively. Data for rate of change in local Hb per 4-week interval is represented here.

End point type

Secondary

End point timeframe

From Baseline up to 16 weeks

End point values	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Number of subjects analysed	19 ^[48]	19 ^[49]	20 ^[50]	16 ^[51]	19 ^[52]	20 ^[53]
Units: g/dL/day
arithmetic mean (standard deviation)
Week 5 (n= 19,19,20,16,19,20)	0.017 ( 0.0258 )	0.03 ( 0.0311 )	0.043 ( 0.0271 )	0.035 ( 0.02 )	0.043 ( 0.0392 )	0.003 ( 0.0187 )
Week 9 (n= 16,13,13,14,12,19)	0.018 ( 0.0254 )	0.016 ( 0.0343 )	0.023 ( 0.0287 )	0.011 ( 0.0218 )	0.03 ( 0.0333 )	-0.002 ( 0.0219 )
Week 13 (n= 13,11,9,13,9,19)	0.012 ( 0.0234 )	0.023 ( 0.0162 )	0.017 ( 0.0206 )	0.015 ( 0.0194 )	0.021 ( 0.0362 )	0.006 ( 0.0189 )
Week 17 (n= 10,11,4,12,6,18)	0.004 ( 0.0217 )	0.003 ( 0.0168 )	-0.013 ( 0.0126 )	0.002 ( 0.0301 )	-0.003 ( 0.0288 )	0.001 ( 0.0237 )

Notes
[48] - mITT
[49] - mITT with number of subjects evaluable for this end point.
[50] - mITT with number of subjects evaluable for this end point.
[51] - mITT with number of subjects evaluable for this end point.
[52] - mITT with number of subjects evaluable for this end point.
[53] - mITT

No statistical analyses for this end point

Secondary: Duration of Treatment Exposure

Top of page

End point title

Duration of Treatment Exposure

End point description

Study treatment exposure measured as duration of exposure, defined as duration in days between the first dose date and last dose date.

End point type

Secondary

End point timeframe

From Baseline up to 16 Weeks

End point values	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Number of subjects analysed	19 ^[54]	21 ^[55]	22 ^[56]	19 ^[57]	20 ^[58]	20 ^[59]
Units: days
arithmetic mean (standard deviation)	88.7 ( 33.56 )	73.8 ( 43.17 )	60.5 ( 36.33 )	84.9 ( 42.33 )	68.5 ( 38.9 )	108.9 ( 16.07 )

Notes
[54] - mITT
[55] - mITT
[56] - mITT
[57] - mITT
[58] - mITT
[59] - mITT

No statistical analyses for this end point

Other pre-specified: Number of Subjects With Adjudicated Serious Adverse Events (SAEs)

Top of page

End point title

Number of Subjects With Adjudicated Serious Adverse Events (SAEs)

End point description

An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs that required adjudication (cardiac and vascular events) were reviewed by an independent Central Adjudication Committee (CAC) comprising of individual clinical experts.

End point type

Other pre-specified

End point timeframe

From the start of study drug administration up to the end of the treatment plus 3 days (Up to 119 days)

End point values	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Number of subjects analysed	19 ^[60]	21 ^[61]	22 ^[62]	19 ^[63]	20 ^[64]	20 ^[65]
Units: Subjects	0	0	1	2	1	2

Notes
[60] - SAF
[61] - SAF
[62] - SAF
[63] - SAF
[64] - SAF
[65] - SAF

No statistical analyses for this end point

Other pre-specified: Change From Baseline in Erythropoietin at Specified Time Point

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End point title

Change From Baseline in Erythropoietin at Specified Time Point

End point description

Erythropoietin was determined at different timepoints using sparse sampling approach. Here, EOT = End of the Treatment, AT = At Trough, 8TO12 = 8 to 12 hours post morning dose time window during which maximum erythropoietin is expected. Here ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group, and ‘99999’ here indicates that data was not calculated. Arithmetic mean and Standard deviation was not estimated if evaluable subjects were less than 3, as 2 or less collected values were not sufficient to calculate a reliable estimation.

End point type

Other pre-specified

End point timeframe

Baseline, Weeks 3, 5, 7, 9, 11, 13, 17 and EOT (last day of Week 16)

End point values	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Number of subjects analysed	17 ^[66]	19 ^[67]	22 ^[68]	16 ^[69]	18 ^[70]	18 ^[71]
Units: international units/liter
arithmetic mean (standard deviation)
Change at Baseline-8TO12 (n= 16,19,22,16,16,17)	9.883 ( 17.8128 )	14.446 ( 10.8185 )	25.204 ( 20.9353 )	8.263 ( 7.5428 )	11.397 ( 11.798 )	1.136 ( 3.3001 )
Change at Week 3 - AT (n= 17,18,18,16,18,17)	5.446 ( 18.5299 )	4.103 ( 7.0193 )	10.011 ( 17.537 )	4.986 ( 9.1742 )	23.852 ( 24.4867 )	-0.509 ( 2.2008 )
Change at Week 5 - AT (n= 15,13,16,12,14,16)	-3.649 ( 14.0522 )	-0.115 ( 2.5551 )	12.883 ( 17.9653 )	-0.183 ( 8.8559 )	23.361 ( 34.4752 )	0.184 ( 4.0278 )
Change at Week 7-8TO12 (n= 16,11,13,11,12,17)	5.417 ( 16.5243 )	13.982 ( 10.9644 )	38.453 ( 29.0531 )	7.102 ( 9.2733 )	27.283 ( 32.9348 )	-0.345 ( 3.8187 )
Change at Week 9 - AT (n= 16,10,10,10,9,17)	-3.316 ( 12.9551 )	-0.67 ( 2.1217 )	12.852 ( 20.9382 )	-1.027 ( 4.0031 )	20.349 ( 41.3935 )	-0.49 ( 4.3537 )
Change at Week 11-8TO12 (n= 2,1,2,2,2,5)	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	0.344 ( 2.7867 )
Change at Week 13 - AT (n= 12,10,5,11,8,17)	3.614 ( 21.4524 )	0.724 ( 2.4879 )	3.288 ( 7.5673 )	0.634 ( 6.4031 )	34.348 ( 62.4966 )	-0.373 ( 4.4162 )
Change at Week 17 - AT (n= 10,10,3,9,4,16)	14.753 ( 50.8998 )	0.38 ( 4.9197 )	21.01 ( 33.6173 )	2.977 ( 4.2593 )	65.613 ( 74.0708 )	-0.484 ( 5.3113 )
Change at Week 17-8TO12 (n= 7,5,1,9,2,15)	17.361 ( 25.8176 )	12.536 ( 17.3382 )	99999 ( 99999 )	10.846 ( 10.8155 )	99999 ( 99999 )	1.659 ( 8.3329 )
Change at EOT - AT (n= 17,16,18,14,16,18)	5.142 ( 40.6265 )	2.689 ( 6.8917 )	6.821 ( 18.863 )	2.31 ( 6.8794 )	22.034 ( 45.2669 )	-0.622 ( 5.2914 )
Change at EOT-8TO12 (n= 10,6,5,10,3,15)	11.976 ( 23.678 )	11.15 ( 15.8751 )	38.834 ( 25.8589 )	9.71 ( 10.8108 )	21.48 ( 21.0086 )	1.659 ( 8.3329 )

Notes
[66] - PDS with number of subjects evaluable for this end point.
[67] - PDS with number of subjects evaluable for this end point.
[68] - PDS
[69] - PDS with number of subjects evaluable for this end point.
[70] - PDS with number of subjects evaluable for this end point.
[71] - PDS with number of subjects evaluable for this end point.

No statistical analyses for this end point

Other pre-specified: Change From Baseline in Reticulocyte Count at Specified Time Point

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End point title

Change From Baseline in Reticulocyte Count at Specified Time Point

End point description

Reticulocytes are slightly immature red blood cells in the blood. Here ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group, and ‘99999’ here indicates that data was not calculated. Arithmetic mean and Standard deviation was not estimated if evaluable subjects were less than 3, as 2 or less collected values were not sufficient to calculate a reliable estimation.

End point type

Other pre-specified

End point timeframe

Baseline, Week 3, 5, 9, 13, 17, EOT (last day of Week 16)

End point values	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Number of subjects analysed	8 ^[72]	7 ^[73]	12 ^[74]	9 ^[75]	11 ^[76]	8 ^[77]
Units: giga/liter
arithmetic mean (standard deviation)
Change at Week 3 (n= 8,7,8,9,10,7)	9.6 ( 16.39 )	27 ( 20.49 )	21.8 ( 31.25 )	31.8 ( 25.81 )	35.5 ( 21.79 )	-2 ( 13.44 )
Change at Week 5 (n= 6,3,7,8,7,7)	1 ( 26.26 )	12.7 ( 11.72 )	11.3 ( 22.51 )	28.4 ( 25.22 )	18.4 ( 11.4 )	-8 ( 9.92 )
Change at Week 9 (n= 8,5,5,6,5,7)	-4.6 ( 10 )	7.6 ( 10.11 )	5.4 ( 4.72 )	23.3 ( 27.43 )	3.6 ( 24.74 )	2 ( 15.35 )
Change at Week 13 (n= 6,5,3,7,5,7)	-9.2 ( 9.37 )	11.2 ( 8.04 )	-4.3 ( 13.28 )	17.4 ( 30.24 )	13.6 ( 9.69 )	4.4 ( 12.87 )
Change at Week 17 (n= 4,4,2,5,2,6)	-8.5 ( 6.45 )	7.5 ( 5.57 )	99999 ( 99999 )	25.4 ( 28.82 )	99999 ( 99999 )	-7.5 ( 15.41 )
Change at EOT (n= 8,6,12,8,11,8)	-13.3 ( 16.02 )	23.8 ( 26.1 )	11.9 ( 32.66 )	20.3 ( 23.18 )	18.6 ( 36.92 )	-11.6 ( 18.81 )

Notes
[72] - PDS with number of subjects evaluable for this end point.
[73] - PDS with number of subjects evaluable for this end point.
[74] - PDS with number of subjects evaluable for this end point.
[75] - PDS with number of subjects evaluable for this end point.
[76] - PDS with number of subjects evaluable for this end point.
[77] - PDS with number of subjects evaluable for this end point.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From the start of study drug administration up to the end of the treatment plus 3 days (Up to 119 days)

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

Molidustat (BAY85-3934) 25 mg Once Daily

Reporting group description

Subjects received orally 1 tablet of Molidustat (BAY85-3934) 25 mg along with 2 tablets of matching placebo in the morning, and approximately 12 hours apart received 3 tablets of matching placebo in the evening daily for 16 weeks.

Reporting group title

Molidustat (BAY85-3934) 50 mg Once Daily

Reporting group description

Reporting group title

Molidustat (BAY85-3934) 75 mg Once Daily

Reporting group description

Reporting group title

Molidustat (BAY85-3934) 25 mg Twice Daily

Reporting group description

Subjects received orally 1 tablet of Molidustat (BAY85-3934) 25 mg along with 2 tablets of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Reporting group title

Molidustat (BAY85-3934) 50 mg Twice Daily

Reporting group description

Subjects received orally 2 tablets of Molidustat (BAY85-3934) (2 * 25 mg) along with 1 tablet of matching placebo in the morning, and approximately 12 hours apart in the evening daily for 16 weeks.

Reporting group title

Placebo Twice Daily

Reporting group description

Subjects received orally 3 placebo tablets matched to Molidustat (BAY85-3934) tablets in the morning and approximately 12 hours apart in the evening daily for 16 weeks.

Serious adverse events	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 19 (26.32%)	1 / 21 (4.76%)	2 / 22 (9.09%)	5 / 19 (26.32%)	1 / 20 (5.00%)	5 / 20 (25.00%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Femur fracture
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Arteriovenous fistula operation
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Gastric polyps
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Chronic kidney disease
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Flank pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Pyelonephritis acute
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urachal abscess
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hyperkalaemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Decreased appetite
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Molidustat (BAY85-3934) 25 mg Once Daily	Molidustat (BAY85-3934) 50 mg Once Daily	Molidustat (BAY85-3934) 75 mg Once Daily	Molidustat (BAY85-3934) 25 mg Twice Daily	Molidustat (BAY85-3934) 50 mg Twice Daily	Placebo Twice Daily
Total subjects affected by non serious adverse events
subjects affected / exposed	13 / 19 (68.42%)	12 / 21 (57.14%)	15 / 22 (68.18%)	13 / 19 (68.42%)	13 / 20 (65.00%)	16 / 20 (80.00%)
Vascular disorders
Hypertension
subjects affected / exposed	3 / 19 (15.79%)	1 / 21 (4.76%)	2 / 22 (9.09%)	2 / 19 (10.53%)	2 / 20 (10.00%)	5 / 20 (25.00%)
occurrences all number	5	1	2	5	3	6
Hypotension
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
Peripheral arterial occlusive disease
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Arterial occlusive disease
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Peripheral artery thrombosis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Peripheral venous disease
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Surgical and medical procedures
Cataract operation
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	1	0	0	0	1
Fatigue
subjects affected / exposed	0 / 19 (0.00%)	2 / 21 (9.52%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	2	0	0	0	0
Generalised oedema
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Oedema
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	2 / 20 (10.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	2	2	0
Oedema peripheral
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	1	0	1
Pyrexia
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
Immune system disorders
Allergy to arthropod bite
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	0	1	0
Reproductive system and breast disorders
Nipple pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Respiratory, thoracic and mediastinal disorders
Bronchospasm
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Cough
subjects affected / exposed	1 / 19 (5.26%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	1	0	0	0	0
Dyspnoea
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	2 / 22 (9.09%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	2	0	0	0
Epistaxis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	0	1	0
Sleep apnoea syndrome
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	2	0	0
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Amylase increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	0	1	0
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	1	0	0	0	1
Blood creatinine increased
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Blood pressure increased
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	1	0	0	0
Electrocardiogram QT prolonged
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	1	0
Glomerular filtration rate decreased
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Haemoglobin decreased
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Lipase increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	0	1	0
Carotid bruit
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Injury, poisoning and procedural complications
Accident
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Foot fracture
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	0	1	0
Foreign body in eye
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Rib fracture
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Contusion
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	1	0
Cardiac disorders
Angina unstable
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Atrioventricular block first degree
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Cardiac failure
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
Cardiac failure chronic
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	0	1	0
Coronary artery disease
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	2	0	0	0	0	0
Extrasystoles
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Sinus bradycardia
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
Sinus tachycardia
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Tachycardia
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Ventricular extrasystoles
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	2 / 22 (9.09%)	1 / 19 (5.26%)	1 / 20 (5.00%)	2 / 20 (10.00%)
occurrences all number	1	0	2	1	1	2
Headache
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Hypoaesthesia
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Myoclonus
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Sciatica
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Syncope
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Cognitive disorder
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Carotid arteriosclerosis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Blood and lymphatic system disorders
Leukopenia
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Thrombocytopenia
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	1	0	0
Eye disorders
Ocular hyperaemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
Abdominal pain upper
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	1	0	0	0
Constipation
subjects affected / exposed	2 / 19 (10.53%)	1 / 21 (4.76%)	2 / 22 (9.09%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	2	1	2	0	0	1
Diarrhoea
subjects affected / exposed	2 / 19 (10.53%)	2 / 21 (9.52%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	2	3	0	0	0	1
Dyspepsia
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Flatulence
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	0	1	0
Gastric polyps
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Gastritis
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Gingival bleeding
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Inguinal hernia
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	1	0	0	0
Nausea
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	1	1	0	0	1
Pancreatitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Vomiting
subjects affected / exposed	2 / 19 (10.53%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	3	0	0	0	0	1
Epigastric discomfort
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Faeces soft
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Hepatobiliary disorders
Biliary colic
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Skin and subcutaneous tissue disorders
Dermatitis contact
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Eczema
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Pruritus
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	2 / 22 (9.09%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	2	1	0	0
Rash
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Skin ulcer
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Onychoclasis
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
Asteatosis
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Renal and urinary disorders
Chronic kidney disease
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)
occurrences all number	0	0	0	0	0	2
Endocrine disorders
Hyperparathyroidism
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Hyperparathyroidism secondary
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	3 / 20 (15.00%)
occurrences all number	0	0	0	0	1	3
Hypothyroidism
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
Back pain
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	1	0	0	0
Muscle spasms
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Musculoskeletal pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Osteoarthritis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Pain in extremity
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	1	0	0	1
Periarthritis
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Chest wall mass
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	1	0	0	1
Conjunctivitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Cystitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0
Gastroenteritis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Herpes zoster
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Infected skin ulcer
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Nasopharyngitis
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	2 / 22 (9.09%)	1 / 19 (5.26%)	3 / 20 (15.00%)	2 / 20 (10.00%)
occurrences all number	1	0	3	1	3	4
Onychomycosis
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Periodontitis
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	1	1
Urinary tract infection
subjects affected / exposed	1 / 19 (5.26%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	3 / 20 (15.00%)
occurrences all number	1	1	0	0	1	3
Escherichia urinary tract infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	1	0	0	0
Respiratory tract infection
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Post procedural infection
subjects affected / exposed	1 / 19 (5.26%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	1	0	0	0	0	0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Gout
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	1	0	0	1
Hyperglycaemia
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	1	0	0	0
Hyperkalaemia
subjects affected / exposed	1 / 19 (5.26%)	2 / 21 (9.52%)	0 / 22 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	3 / 20 (15.00%)
occurrences all number	1	2	0	0	1	3
Hyperuricaemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	1	0	1
Hypokalaemia
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Hyponatraemia
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Iron deficiency
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	1
Metabolic acidosis
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	1 / 22 (4.55%)	0 / 19 (0.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)
occurrences all number	0	1	1	0	0	2
Vitamin D deficiency
subjects affected / exposed	0 / 19 (0.00%)	1 / 21 (4.76%)	0 / 22 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	1	0	0	0	0
Decreased appetite
subjects affected / exposed	0 / 19 (0.00%)	0 / 21 (0.00%)	0 / 22 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 20 (0.00%)
occurrences all number	0	0	0	1	0	0

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Were there any global substantial amendments to the protocol? Yes

08 Aug 2014

This protocol amendment included the following modifications: mean screening Hb value was changed from less than 10 to less than or equal to 10.5 g/dL, heart failure was added to the list of SAEs to be adjudicated, End of the treatment (EoT) text was corrected, status of the BAY85-3934 phase I data was updated, concomitant medications in the exclusion criterion was clarified for the study population, timing of Hb assessment was adjusted from within 2 days to 3 days prior to visit to improve logistical planning of visits at sites, to increase study feasibility for subjects, some PK / PD assessments were removed, coagulation tests at baseline and month 1 and TSH at month 1 were added to calculate the change from baseline, modifications were made to improve the general clarity of the protocol.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

‘99999’ in the posting indicates that data was not calculated as evaluable subjects were less than 3, collected values were not sufficient to calculate a reliable estimation. Decimal places were automatically truncated if last decimal equals zero.

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change in Local Laboratory Hemoglobin Level From Baseline to the Study Evaluation Period (Last 4 Weeks of Treatment Period)

Primary: Change in Local Laboratory Hemoglobin Level From Baseline to the Study Evaluation Period (Last 4 Weeks of Treatment Period)

Secondary: Change in Local Laboratory Hemoglobin Level From Baseline to Multiple Time Points in First 12 Weeks of Treatment Period

Secondary: Change in Local Laboratory Hemoglobin Level From Baseline to Multiple Time Points in First 12 Weeks of Treatment Period

Secondary: Rate of Change in Hemoglobin Level Over Time

Secondary: Rate of Change in Hemoglobin Level Over Time

Secondary: Duration of Treatment Exposure

Secondary: Duration of Treatment Exposure

Other pre-specified: Number of Subjects With Adjudicated Serious Adverse Events (SAEs)

Other pre-specified: Number of Subjects With Adjudicated Serious Adverse Events (SAEs)

Other pre-specified: Change From Baseline in Erythropoietin at Specified Time Point

Other pre-specified: Change From Baseline in Erythropoietin at Specified Time Point

Other pre-specified: Change From Baseline in Reticulocyte Count at Specified Time Point

Other pre-specified: Change From Baseline in Reticulocyte Count at Specified Time Point

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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