Download PDF

Clinical Trial Results:
An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated with Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis

Summary
EudraCT number	2021-002013-34
Trial protocol	ES IT FR AT BE PL Outside EU/EEA
Global end of trial date	17 Mar 2025

Results information
Results version number	v1(current)
This version publication date	23 Oct 2025
First version publication date	23 Oct 2025
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

214066

ISRCTN number

US NCT number

NCT05682326

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

79 New Oxford Street, London, United Kingdom, WC1A 1DG

Public contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com

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

Yes

EMA paediatric investigation plan number(s)

EMEA-001452-PIP01-13

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

17 Mar 2025

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

17 Mar 2025

Was the trial ended prematurely?

Yes

Main objective of the trial

Describe the safety of daprodustat, overall (all ages) and in each age group.

Protection of trial subjects

Background therapy

Evidence for comparator

Actual start date of recruitment

06 Sep 2023

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Japan: 3

Country: Number of subjects enrolled

Korea, Republic of: 1

Worldwide total number of subjects

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

Top of page

Recruitment details

Participants enrolled in 2 sub-trials under master protocol. The non-dialysis (ND) sub-trial enrolled pediatric participants with anemia associated with chronic kidney disease (CKD) not yet requiring dialysis and the dialysis (D) sub-trial enrolled pediatric participants with anemia associated with CKD requiring dialysis, both in non-US countries.

Screening details

A total of 4 participants were enrolled. As pre-specified in protocol design, data for the 2 sub-trials (ND and D) have been presented in two arms for this study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Participants requiring Dialysis (D)

Arm description

Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).

Arm type

Experimental

Investigational medicinal product name

Daprodustat

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral daprodustat (1 to 24 mg QD equivalent) for 52 weeks, dose adjusted per Baseline Hgb and clinical status.

Participants not yet requiring Dialysis (ND)

Arm description

Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).

Arm type

Experimental

Investigational medicinal product name

Daprodustat

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral daprodustat (1 to 24 mg QD equivalent) for 52 weeks, dose adjusted per baseline Hgb and clinical status.

Number of subjects in period 1	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Started	2	2
Completed	1	2
Not completed	1	0
Consent withdrawn by subject	1	-

Baseline characteristics

Top of page

Reporting group title

Participants requiring Dialysis (D)

Reporting group description

Reporting group title

Participants not yet requiring Dialysis (ND)

Reporting group description

Reporting group values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)	Total
Number of subjects	2	2	4
Age Categorical
Units: Participants
12 to <18 years	2	2	4
Sex: Female, Male
Units: Participants
Female	2	0	2
Male	0	2	2
Race/Ethnicity, Customized
“All Other Races” category (Asian - East Asian Heritage and Asian - Japanese Heritage where 0<n<11) are combined into one category to maintain participant confidentiality and privacy.
Units: Subjects
All Other Races	2	2	4

End points

Top of page

Reporting group title

Participants requiring Dialysis (D)

Reporting group description

Reporting group title

Participants not yet requiring Dialysis (ND)

Reporting group description

Primary: Number of participants with any adverse events (AEs) and serious adverse events (SAEs)

Top of page

End point title

Number of participants with any adverse events (AEs) and serious adverse events (SAEs) ^[1]

End point description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other situations as per medical and scientific judgement of the Investigator. The analysis was performed on the Safety Set that included all participants who were enrolled and took at least one dose of study medication.

End point type

Primary

End point timeframe

Up to 56 weeks

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[2]	2 ^[3]
Units: Participants
Any AEs	2	2
Any SAEs	1	0

Notes
[2] - Safety Set
[3] - Safety Set

No statistical analyses for this end point

Primary: Number of participants with adverse event of special interests (AESIs)

Top of page

End point title

Number of participants with adverse event of special interests (AESIs) ^[4]

End point description

AESIs are AEs of scientific interest specific to the drug class as per investigator assessment. AESI included: Death, Myocardial Infarction (MI), stroke, Heart Failure (HF), thromboembolic events, thrombosis of vascular access, Thrombosis and/or tissue ischemia secondary to excessive erythropoiesis, New diagnosis of hypertension or worsening of existing hypertension, Cancer related mortality and tumor progression and recurrence, Esophageal and gastric erosions. Number of participants with any AESIs have been presented. Safety Set.

End point type

Primary

End point timeframe

Up to 56 weeks

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[5]	2 ^[6]
Units: Participants	0	0

Notes
[5] - Safety Set
[6] - Safety Set

No statistical analyses for this end point

Primary: Number of participants with AEs leading to study intervention discontinuation

Top of page

End point title

Number of participants with AEs leading to study intervention discontinuation ^[7]

End point description

All AEs leading to study intervention discontinuation were collected. Number of participants with any AEs leading to study intervention discontinuation have been presented. Safety Set.

End point type

Primary

End point timeframe

Up to 52 weeks

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[8]	2 ^[9]
Units: Participants	0	0

Notes
[8] - Safety Set
[9] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameter: Hematocrit

Top of page

End point title

Change from Baseline in hematology parameter: Hematocrit

End point description

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[10]	2 ^[11]
Units: Percentage of red blood cells in blood
arithmetic mean (standard deviation)
Week 4, n=1,2	0.0160 ( 99999 )	0.0030 ( 0.03818 )
Week 8, n=1,2	0.0530 ( 99999 )	0.0025 ( 0.03889 )
Week 12, n=1,2	-0.0280 ( 99999 )	0.0135 ( 0.01485 )
Week 16, n=1,2	-0.0200 ( 99999 )	-0.0185 ( 0.03889 )
Week 20, n=1,2	0.0000 ( 99999 )	-0.0005 ( 0.01909 )
Week 24, n=1,2	0.0050 ( 99999 )	0.0060 ( 0.02687 )
Week 28, n=1,2	0.0340 ( 99999 )	-0.0050 ( 0.03536 )
Week 32, n=1,1	0.0350 ( 99999 )	0.0370 ( 99999 )
Week 36, n=1,2	0.0070 ( 99999 )	0.0095 ( 0.02333 )
Week 40, n=1,2	-0.0220 ( 99999 )	0.0270 ( 0.04667 )
Week 44, n=1,2	-0.0020 ( 99999 )	-0.0060 ( 0.03677 )
Week 48, n=0,2	-88888 ( 88888 )	0.0035 ( 0.01909 )
Week 52, n=1,2	-0.0320 ( 99999 )	0.0020 ( 0.01980 )

Notes
[10] - Safety Set
[11] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameter: Reticulocytes/Erythrocytes

Top of page

End point title

Change from Baseline in hematology parameter: Reticulocytes/Erythrocytes

End point description

Blood samples were collected to analyze the hematology parameter: Reticulocytes/Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[12]	2 ^[13]
Units: Ratio of Reticulocytes to Erythrocytes
arithmetic mean (standard deviation)
Week 4, n=1,2	0.0080 ( 99999 )	-0.0039 ( 0.00686 )
Week 8, n=1,2	-0.0020 ( 99999 )	0.0031 ( 0.00134 )
Week 12, n=1,2	0.0060 ( 99999 )	-0.0012 ( 0.00594 )
Week 16, n=1,2	0.0100 ( 99999 )	-0.0024 ( 0.00481 )
Week 20, n=1,2	0.0110 ( 99999 )	0.0001 ( 0.00693 )
Week 24, n=1,2	0.0060 ( 99999 )	-0.0020 ( 0.00700 )
Week 28, n=1,2	0.0040 ( 99999 )	0.0007 ( 0.00467 )
Week 32, n=1,1	0.0030 ( 99999 )	-0.0037 ( 99999 )
Week 36, n=1,2	0.0020 ( 99999 )	0.0010 ( 0.00573 )
Week 40, n=1,2	0.0070 ( 99999 )	-0.0020 ( 0.00849 )
Week 44, n=1,2	0.0100 ( 99999 )	0.0010 ( 0.00714 )
Week 48, n=0,2	-88888 ( 88888 )	0.0026 ( 0.00771 )
Week 52, n=1,2	0.0040 ( 99999 )	0.0018 ( 0.00453 )

Notes
[12] - Safety Set
[13] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameter: Erythrocytes

Top of page

End point title

Change from Baseline in hematology parameter: Erythrocytes

End point description

Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[14]	2 ^[15]
Units: Trillion cells per Liter (10^12 cells/L)
arithmetic mean (standard deviation)
Week 4, n=1,2	0.130 ( 99999 )	0.060 ( 0.4243 )
Week 8, n=1,2	0.480 ( 99999 )	0.045 ( 0.4313 )
Week 12, n=1,2	-0.350 ( 99999 )	0.060 ( 0.2546 )
Week 16, n=1,2	-0.350 ( 99999 )	-0.280 ( 0.5374 )
Week 20, n=1,2	0.010 ( 99999 )	-0.050 ( 0.2970 )
Week 24, n=1,2	0.030 ( 99999 )	0.025 ( 0.3889 )
Week 28, n=1,2	0.250 ( 99999 )	-0.095 ( 0.4879 )
Week 32, n=1,1	0.350 ( 99999 )	0.350 ( 99999 )
Week 36, n=1,2	0.030 ( 99999 )	0.050 ( 0.3111 )
Week 40, n=1,2	-0.330 ( 99999 )	0.310 ( 0.4808 )
Week 44, n=1,2	-0.260 ( 99999 )	-0.080 ( 0.5515 )
Week 48, n=0,2	-88888 ( 88888 )	-0.025 ( 0.2758 )
Week 52, n=1,2	-0.490 ( 99999 )	-0.050 ( 0.2687 )

Notes
[14] - Safety Set
[15] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count

Top of page

End point title

Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count

End point description

Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[16]	2 ^[17]
Units: Giga cells per Liter (10^9 cells/L)
arithmetic mean (standard deviation)
Basophils: Week 4, n=1,2	0.0120 ( 99999 )	0.0007 ( 0.01509 )
Basophils: Week 8, n=1,2	-0.0177 ( 99999 )	0.0087 ( 0.01232 )
Basophils: Week 12, n=1,2	-0.0011 ( 99999 )	0.0093 ( 0.01312 )
Basophils: Week 16, n=1,2	-0.0062 ( 99999 )	-0.0038 ( 0.02292 )
Basophils: Week 20, n=1,2	0.0085 ( 99999 )	0.0162 ( 0.02295 )
Basophils: Week 24, n=1,2	-0.0044 ( 99999 )	0.0066 ( 0.02353 )
Basophils: Week 28, n=1,2	0.0182 ( 99999 )	0.0003 ( 0.01458 )
Basophils: Week 32, n=1,1	-0.0209 ( 99999 )	0.0314 ( 99999 )
Basophils: Week 36, n=1,2	-0.0091 ( 99999 )	0.0051 ( 0.02139 )
Basophils: Week 40, n=1,2	-0.0020 ( 99999 )	0.0063 ( 0.00522 )
Basophils: Week 44, n=1,2	-0.0091 ( 99999 )	0.0001 ( 0.00017 )
Basophils: Week 48, n=0,2	-88888 ( 88888 )	0.0059 ( 0.00833 )
Basophils: Week 52, n=1,2	0.0012 ( 99999 )	-0.0001 ( 0.00008 )
Eosinophils: Week 4, n=1,2	0.0146 ( 99999 )	0.4193 ( 0.63542 )
Eosinophils: Week 8, n=1,2	-0.0962 ( 99999 )	0.2385 ( 0.30899 )
Eosinophils: Week 12, n=1,2	-0.0072 ( 99999 )	0.2547 ( 0.11973 )
Eosinophils: Week 16, n=1,2	0.0239 ( 99999 )	0.1184 ( 0.15326 )
Eosinophils: Week 20, n=1,2	-0.0037 ( 99999 )	0.0989 ( 0.13988 )
Eosinophils: Week 24, n=1,2	0.0203 ( 99999 )	0.0698 ( 0.18356 )
Eosinophils: Week 28, n=1,2	-0.0578 ( 99999 )	0.0238 ( 0.07607 )
Eosinophils: Week 32, n=1,1	-0.1571 ( 99999 )	0.2913 ( 99999 )
Eosinophils: Week 36, n=1,2	-0.0775 ( 99999 )	0.0395 ( 0.14069 )
Eosinophils: Week 40, n=1,2	-0.1208 ( 99999 )	0.0357 ( 0.07683 )
Eosinophils: Week 44, n=1,2	-0.0522 ( 99999 )	0.0395 ( 0.02754 )
Eosinophils: Week 48, n=0,2	-88888 ( 88888 )	0.1645 ( 0.10537 )
Eosinophils: Week 52, n=1,2	-0.0628 ( 99999 )	0.0390 ( 0.00136 )
Lymphocytes: Week 4, n=1,2	0.2799 ( 99999 )	-0.2606 ( 0.01499 )
Lymphocytes: Week 8, n=1,2	0.4370 ( 99999 )	-0.4114 ( 0.49299 )
Lymphocytes: Week 12, n=1,2	-0.2165 ( 99999 )	-0.2552 ( 0.57253 )
Lymphocytes: Week 16, n=1,2	-0.2907 ( 99999 )	-0.2009 ( 0.40885 )
Lymphocytes: Week 20, n=1,2	0.1325 ( 99999 )	-0.3649 ( 0.58710 )
Lymphocytes: Week 24, n=1,2	-0.1535 ( 99999 )	-0.3050 ( 0.58684 )
Lymphocytes: Week 28, n=1,2	0.0289 ( 99999 )	-0.2517 ( 0.50673 )
Lymphocytes: Week 32, n=1,1	-1.1501 ( 99999 )	0.6357 ( 99999 )
Lymphocytes: Week 36, n=1,2	0.0581 ( 99999 )	-0.4619 ( 1.00143 )
Lymphocytes: Week 40, n=1,2	-0.2134 ( 99999 )	-0.4961 ( 0.05108 )
Lymphocytes: Week 44, n=1,2	0.5638 ( 99999 )	-0.4021 ( 0.50620 )
Lymphocytes: Week 48, n=0,2	-88888 ( 88888 )	-0.1701 ( 0.33923 )
Lymphocytes: Week 52, n=1,2	0.4700 ( 99999 )	-0.5256 ( 0.60026 )
Monocytes: Week 4, n=1,2	0.0408 ( 99999 )	-0.0318 ( 0.03079 )
Monocytes: Week 8, n=1,2	0.1094 ( 99999 )	0.0230 ( 0.15981 )
Monocytes: Week 12, n=1,2	-0.0258 ( 99999 )	0.0536 ( 0.01924 )
Monocytes: Week 16, n=1,2	-0.0289 ( 99999 )	0.0148 ( 0.00684 )
Monocytes: Week 20, n=1,2	0.0132 ( 99999 )	-0.0307 ( 0.11217 )
Monocytes: Week 24, n=1,2	-0.0404 ( 99999 )	-0.0310 ( 0.04098 )
Monocytes: Week 28, n=1,2	0.0169 ( 99999 )	-0.0314 ( 0.06868 )
Monocytes: Week 32, n=1,1	-0.2902 ( 99999 )	0.0410 ( 99999 )
Monocytes: Week 36, n=1,2	-0.0410 ( 99999 )	-0.0596 ( 0.01360 )
Monocytes: Week 40, n=1,2	-0.0708 ( 99999 )	0.0884 ( 0.20985 )
Monocytes: Week 44, n=1,2	0.0601 ( 99999 )	-0.0110 ( 0.02690 )
Monocytes: Week 48, n=0,2	-88888 ( 88888 )	0.0492 ( 0.04132 )
Monocytes: Week 52, n=1,2	0.0164 ( 99999 )	-0.0112 ( 0.01583 )
Neutrophils: Week 4, n=1,2	-0.1973 ( 99999 )	-0.1626 ( 0.16602 )
Neutrophils: Week 8, n=1,2	-3.5926 ( 99999 )	0.4712 ( 1.43005 )
Neutrophils: Week 12, n=1,2	-0.1094 ( 99999 )	0.4876 ( 0.20136 )
Neutrophils: Week 16, n=1,2	-1.7681 ( 99999 )	1.3315 ( 1.27070 )
Neutrophils: Week 20, n=1,2	-0.8705 ( 99999 )	-0.0296 ( 0.38241 )
Neutrophils: Week 24, n=1,2	-1.2919 ( 99999 )	0.2346 ( 0.30353 )
Neutrophils: Week 28, n=1,2	1.6839 ( 99999 )	-0.1160 ( 0.33096 )
Neutrophils: Week 32, n=1,1	-5.3517 ( 99999 )	1.1306 ( 99999 )
Neutrophils: Week 36, n=1,2	1.2095 ( 99999 )	0.4269 ( 0.70272 )
Neutrophils: Week 40, n=1,2	-0.2730 ( 99999 )	1.0158 ( 0.85667 )
Neutrophils: Week 44, n=1,2	0.5974 ( 99999 )	0.0185 ( 0.11095 )
Neutrophils: Week 48, n=0,2	-88888 ( 88888 )	0.3055 ( 0.11948 )
Neutrophils: Week 52, n=1,2	-0.0248 ( 99999 )	0.6728 ( 0.91533 )
Leukocytes: Week 4, n=1,2	0.150 ( 99999 )	-0.045 ( 0.7849 )
Leukocytes: Week 8, n=1,2	-3.160 ( 99999 )	0.315 ( 2.4254 )
Leukocytes: Week 12, n=1,2	-0.360 ( 99999 )	0.510 ( 0.5798 )
Leukocytes: Week 16, n=1,2	-2.070 ( 99999 )	1.240 ( 0.6505 )
Leukocytes: Week 20, n=1,2	-0.720 ( 99999 )	-0.315 ( 1.2516 )
Leukocytes: Week 24, n=1,2	-1.470 ( 99999 )	-0.060 ( 1.1879 )
Leukocytes: Week 28, n=1,2	1.690 ( 99999 )	-0.385 ( 1.0112 )
Leukocytes: Week 32, n=1,1	-6.970 ( 99999 )	2.130 ( 99999 )
Leukocytes: Week 36, n=1,2	1.140 ( 99999 )	-0.070 ( 1.8809 )
Leukocytes: Week 40, n=1,2	-0.680 ( 99999 )	0.605 ( 0.9970 )
Leukocytes: Week 44, n=1,2	1.160 ( 99999 )	-0.390 ( 0.7212 )
Leukocytes: Week 48, n=0,2	-88888 ( 88888 )	0.310 ( 0.4384 )
Leukocytes: Week 52, n=1,2	0.400 ( 99999 )	0.170 ( 0.3253 )
Platelet count: Week 4, n=1,2	16.0 ( 99999 )	-30.0 ( 26.87 )
Platelet count: Week 8, n=1,2	-31.0 ( 99999 )	-41.5 ( 34.65 )
Platelet count: Week 12, n=1,2	-11.0 ( 99999 )	-32.0 ( 39.60 )
Platelet count: Week 16, n=1,2	-5.0 ( 99999 )	-47.0 ( 14.14 )
Platelet count: Week 20, n=1,2	5.0 ( 99999 )	-39.5 ( 27.58 )
Platelet count: Week 24, n=1,2	-11.0 ( 99999 )	-10.0 ( 7.07 )
Platelet count: Week 28, n=1,2	10.0 ( 99999 )	-14.5 ( 6.36 )
Platelet count: Week 32, n=1,1	6.0 ( 99999 )	1.0 ( 99999 )
Platelet count: Week 36, n=1,2	-4.0 ( 99999 )	-25.0 ( 0.00 )
Platelet count: Week 40, n=1,2	23.0 ( 99999 )	-18.5 ( 27.58 )
Platelet count: Week 44, n=1,2	28.0 ( 99999 )	-7.5 ( 37.48 )
Platelet count: Week 48, n=0,2	-88888 ( 88888 )	-36.0 ( 35.36 )
Platelet count: Week 52, n=1,2	30.0 ( 99999 )	11.0 ( 65.05 )

Notes
[16] - Safety Set
[17] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameter: Erythrocytes Mean Corpuscular Volume

Top of page

End point title

Change from Baseline in hematology parameter: Erythrocytes Mean Corpuscular Volume

End point description

Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[18]	2 ^[19]
Units: Femtoliter (fL)
arithmetic mean (standard deviation)
Week 4, n=1,2	1.00 ( 99999 )	-0.45 ( 0.919 )
Week 8, n=1,2	2.10 ( 99999 )	-0.35 ( 0.919 )
Week 12, n=1,2	1.00 ( 99999 )	2.00 ( 1.414 )
Week 16, n=1,2	3.10 ( 99999 )	1.15 ( 1.344 )
Week 20, n=1,2	-0.20 ( 99999 )	0.85 ( 1.202 )
Week 24, n=1,2	0.60 ( 99999 )	0.95 ( 1.202 )
Week 28, n=1,2	2.60 ( 99999 )	0.70 ( 1.131 )
Week 32, n=1,1	0.80 ( 99999 )	1.90 ( 99999 )
Week 36, n=1,2	1.00 ( 99999 )	1.25 ( 0.495 )
Week 40, n=1,2	2.10 ( 99999 )	0.35 ( 1.626 )
Week 44, n=1,2	5.60 ( 99999 )	0.20 ( 1.980 )
Week 48, n=0,2	-88888 ( 88888 )	1.35 ( 0.778 )
Week 52, n=1,2	3.40 ( 99999 )	1.45 ( 0.495 )

Notes
[18] - Safety Set
[19] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin

Top of page

End point title

Change from Baseline in hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin

End point description

Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[20]	2 ^[21]
Units: Picogram (pg)
arithmetic mean (standard deviation)
Week 4, n=1,2	0.30 ( 99999 )	0.00 ( 0.849 )
Week 8, n=1,2	0.20 ( 99999 )	0.45 ( 0.071 )
Week 12, n=1,2	0.70 ( 99999 )	0.70 ( 0.141 )
Week 16, n=1,2	1.30 ( 99999 )	0.95 ( 0.212 )
Week 20, n=1,2	0.90 ( 99999 )	0.85 ( 0.212 )
Week 24, n=1,2	1.30 ( 99999 )	0.70 ( 0.000 )
Week 28, n=1,2	1.20 ( 99999 )	1.45 ( 0.212 )
Week 32, n=1,1	1.00 ( 99999 )	0.40 ( 99999 )
Week 36, n=1,2	0.50 ( 99999 )	1.15 ( 0.636 )
Week 40, n=1,2	1.60 ( 99999 )	0.55 ( 0.212 )
Week 44, n=1,2	2.10 ( 99999 )	0.55 ( 1.061 )
Week 48, n=0,2	-88888 ( 88888 )	0.80 ( 0.566 )
Week 52, n=1,2	1.80 ( 99999 )	1.95 ( 1.626 )

Notes
[20] - Safety Set
[21] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)

Top of page

End point title

Change from Baseline in clinical chemistry parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)

End point description

Blood samples were collected to analyze the clinical chemistry parameters: Calcium, Potassium, Sodium and BUN. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[22]	2 ^[23]
Units: millimoles per liter (mmol/L)
arithmetic mean (standard deviation)
Calcium: Week 4, n=1,2	0.0749 ( 99999 )	-0.1123 ( 0.05293 )
Calcium: Week 8, n=1,2	-0.1248 ( 99999 )	-0.1248 ( 0.10585 )
Calcium: Week 12, n=1,2	-0.0499 ( 99999 )	-0.1372 ( 0.12350 )
Calcium: Week 16, n=1,2	0.0000 ( 99999 )	-0.1372 ( 0.12350 )
Calcium: Week 20, n=1,2	0.0250 ( 99999 )	-0.0873 ( 0.08821 )
Calcium: Week 24, n=1,2	0.0250 ( 99999 )	-0.0873 ( 0.15878 )
Calcium: Week 28, n=1,2	-0.0499 ( 99999 )	-0.1871 ( 0.08821 )
Calcium: Week 32, n=1,1	0.0250 ( 99999 )	0.0000 ( 99999 )
Calcium: Week 36, n=1,2	0.1248 ( 99999 )	-0.1372 ( 0.12350 )
Calcium: Week 40, n=1,2	0.0000 ( 99999 )	-0.0624 ( 0.05293 )
Calcium: Week 44, n=1,2	0.1248 ( 99999 )	-0.1248 ( 0.07057 )
Calcium: Week 48, n=0,2	-88888 ( 88888 )	-0.1123 ( 0.08821 )
Calcium: Week 52, n=1,2	0.0998 ( 99999 )	-0.1747 ( 0.14114 )
Potassium: Week 4, n=1,2	0.40 ( 99999 )	-0.35 ( 0.354 )
Potassium: Week 8, n=1,2	0.30 ( 99999 )	-0.40 ( 0.000 )
Potassium: Week 12, n=1,2	0.40 ( 99999 )	-0.30 ( 0.283 )
Potassium: Week 16, n=1,2	0.10 ( 99999 )	-0.45 ( 0.212 )
Potassium: Week 20, n=1,2	0.30 ( 99999 )	-0.10 ( 0.424 )
Potassium: Week 24, n=1,2	0.20 ( 99999 )	-0.05 ( 0.495 )
Potassium: Week 28, n=1,2	0.30 ( 99999 )	-0.55 ( 0.354 )
Potassium: Week 32, n=1,1	0.30 ( 99999 )	-0.30 ( 99999 )
Potassium: Week 36, n=1,2	0.20 ( 99999 )	-0.35 ( 0.071 )
Potassium: Week 40, n=1,2	0.40 ( 99999 )	-0.55 ( 0.354 )
Potassium: Week 44, n=1,2	0.20 ( 99999 )	-0.40 ( 0.424 )
Potassium: Week 48, n=0,2	-88888 ( 88888 )	-0.25 ( 0.495 )
Potassium: Week 52, n=1,2	0.50 ( 99999 )	-0.20 ( 0.283 )
Sodium: Week 4, n=1,2	0.0 ( 99999 )	0.5 ( 3.54 )
Sodium: Week 8, n=1,2	0.0 ( 99999 )	-0.5 ( 0.71 )
Sodium: Week 12, n=1,2	-1.0 ( 99999 )	0.0 ( 0.00 )
Sodium: Week 16, n=1,2	0.0 ( 99999 )	0.5 ( 3.54 )
Sodium: Week 20, n=1,2	1.0 ( 99999 )	-2.0 ( 2.83 )
Sodium: Week 24, n=1,2	0.0 ( 99999 )	0.5 ( 2.12 )
Sodium: Week 28, n=1,2	-2.0 ( 99999 )	-0.5 ( 3.54 )
Sodium: Week 32, n=1,1	0.0 ( 99999 )	-3.0 ( 99999 )
Sodium: Week 36, n=1,2	0.0 ( 99999 )	-0.5 ( 2.12 )
Sodium: Week 40, n=1,2	0.0 ( 99999 )	-2.5 ( 3.54 )
Sodium: Week 44, n=1,2	1.0 ( 99999 )	-0.5 ( 4.95 )
Sodium: Week 48, n=0,2	-88888 ( 88888 )	-1.0 ( 2.83 )
Sodium: Week 52, n=1,2	-1.0 ( 99999 )	0.5 ( 2.12 )
BUN: Week 4, n=1,2	0.9996 ( 99999 )	0.0893 ( 3.40790 )
BUN: Week 8, n=1,2	-0.2142 ( 99999 )	2.1242 ( 4.06424 )
BUN: Week 12, n=1,2	1.7136 ( 99999 )	0.6962 ( 2.54961 )
BUN: Week 16, n=1,2	1.3923 ( 99999 )	0.1964 ( 4.77106 )
BUN: Week 20, n=1,2	0.7854 ( 99999 )	0.8390 ( 0.83304 )
BUN: Week 24, n=1,2	0.6069 ( 99999 )	0.0000 ( 3.02925 )
BUN: Week 28, n=1,2	3.6057 ( 99999 )	0.0893 ( 2.90303 )
BUN: Week 32, n=1,1	2.2134 ( 99999 )	1.4280 ( 99999 )
BUN: Week 36, n=1,2	4.1055 ( 99999 )	0.4820 ( 1.33792 )
BUN: Week 40, n=1,2	-0.6426 ( 99999 )	4.1948 ( 7.19446 )
BUN: Week 44, n=1,2	2.2848 ( 99999 )	1.1603 ( 2.90303 )
BUN: Week 48, n=0,2	-88888 ( 88888 )	0.4463 ( 2.90303 )
BUN: Week 52, n=1,2	1.9278 ( 99999 )	1.1424 ( 4.94777 )

Notes
[22] - Safety Set
[23] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameter: Creatinine

Top of page

End point title

Change from Baseline in clinical chemistry parameter: Creatinine

End point description

Blood samples were collected to analyze the clinical chemistry parameter: Creatinine. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[24]	2 ^[25]
Units: micromoles per Liter (µmol/L)
arithmetic mean (standard deviation)
Week 4, n=1,2	21.2160 ( 99999 )	-3.0940 ( 5.62574 )
Week 8, n=1,2	139.6720 ( 99999 )	-0.4420 ( 9.37624 )
Week 12, n=1,2	-1.7680 ( 99999 )	3.9780 ( 10.62640 )
Week 16, n=1,2	4.4200 ( 99999 )	14.5860 ( 19.37755 )
Week 20, n=1,2	-22.1000 ( 99999 )	12.3760 ( 6.25082 )
Week 24, n=1,2	-5.3040 ( 99999 )	24.3100 ( 26.87854 )
Week 28, n=1,2	78.6760 ( 99999 )	13.7020 ( 13.12673 )
Week 32, n=1,1	83.9800 ( 99999 )	48.6200 ( 99999 )
Week 36, n=1,2	95.4720 ( 99999 )	32.2660 ( 45.63101 )
Week 40, n=1,2	100.7760 ( 99999 )	65.4160 ( 75.00989 )
Week 44, n=1,2	115.8040 ( 99999 )	49.5040 ( 57.50758 )
Week 48, n=0,2	-88888 ( 88888 )	56.1340 ( 65.63365 )
Week 52, n=1,2	151.1640 ( 99999 )	73.8140 ( 94.38744 )

Notes
[24] - Safety Set
[25] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

Top of page

End point title

Change from Baseline in clinical chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

End point description

Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[26]	2 ^[27]
Units: International units per liter
arithmetic mean (standard deviation)
ALT: Week 4, n=1,2	2.0 ( 99999 )	-2.0 ( 0.00 )
ALT: Week 8, n=1,2	2.0 ( 99999 )	-2.5 ( 0.71 )
ALT: Week 12, n=1,2	2.0 ( 99999 )	-3.5 ( 0.71 )
ALT: Week 24, n=1,2	0.0 ( 99999 )	-3.5 ( 2.12 )
ALT: Week 32, n=1,1	1.0 ( 99999 )	-5.0 ( 99999 )
ALT: Week 36, n=1,2	-1.0 ( 99999 )	-1.0 ( 0.00 )
ALT: Week 40, n=1,2	-2.0 ( 99999 )	-3.5 ( 2.12 )
ALT: Week 48, n=0,2	-88888 ( 88888 )	-0.5 ( 4.95 )
ALT: Week 52, n=1,2	0.0 ( 99999 )	-4.5 ( 0.71 )
ALP: Week 4, n=1,1	34.0 ( 99999 )	-29.0 ( 99999 )
ALP: Week 8, n=1,1	13.0 ( 99999 )	77.0 ( 99999 )
ALP: Week 12, n=1,1	31.0 ( 99999 )	123.0 ( 99999 )
ALP: Week 24, n=1,1	36.0 ( 99999 )	23.0 ( 99999 )
ALP: Week 32, n=1,1	29.0 ( 99999 )	141.0 ( 99999 )
ALP: Week 36, n=1,1	14.0 ( 99999 )	113.0 ( 99999 )
ALP: Week 40, n=1,1	2.0 ( 99999 )	100.0 ( 99999 )
ALP: Week 48, n=0,1	-88888 ( 88888 )	35.0 ( 99999 )
ALP: Week 52, n=1,1	2.0 ( 99999 )	46.0 ( 99999 )
AST: Week 4, n=1,2	3.0 ( 99999 )	-1.0 ( 1.41 )
AST: Week 8, n=1,2	5.0 ( 99999 )	-1.0 ( 1.41 )
AST: Week 12, n=1,2	0.0 ( 99999 )	-4.0 ( 2.83 )
AST: Week 24, n=1,2	-1.0 ( 99999 )	-5.5 ( 3.54 )
AST: Week 32, n=1,1	1.0 ( 99999 )	-4.0 ( 99999 )
AST: Week 36, n=1,2	-2.0 ( 99999 )	-2.5 ( 3.54 )
AST: Week 40, n=1,2	-3.0 ( 99999 )	-4.0 ( 4.24 )
AST: Week 48, n=0,2	-88888 ( 88888 )	-4.5 ( 4.95 )
AST: Week 52, n=1,2	-2.0 ( 99999 )	-6.0 ( 4.24 )

Notes
[26] - Safety Set
[27] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameters: Bilirubin and Direct Bilirubin

Top of page

End point title

Change from Baseline in clinical chemistry parameters: Bilirubin and Direct Bilirubin

End point description

Blood samples were collected to analyze the clinical chemistry parameters: Bilirubin and Direct Bilirubin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[28]	2 ^[29]
Units: micromoles per Liter (µmol/L)
arithmetic mean (standard deviation)
Bilirubin: Week 4, n=1,2	0.0000 ( 99999 )	1.1115 ( 1.57190 )
Bilirubin: Week 8, n=1,2	0.0000 ( 99999 )	1.5390 ( 2.17647 )
Bilirubin: Week 12, n=1,2	0.0000 ( 99999 )	3.4200 ( 4.83661 )
Bilirubin: Week 24, n=1,2	-1.7100 ( 99999 )	4.9590 ( 2.17647 )
Bilirubin: Week 32, n=1,1	0.0000 ( 99999 )	3.4200 ( 99999 )
Bilirubin: Week 36, n=1,2	0.0000 ( 99999 )	1.9665 ( 0.36275 )
Bilirubin: Week 40, n=1,2	0.0000 ( 99999 )	3.5910 ( 0.24183 )
Bilirubin: Week 48, n=0,2	-88888 ( 88888 )	-0.3420 ( 0.48366 )
Bilirubin: Week 52, n=1,2	-1.7100 ( 99999 )	1.6245 ( 2.29739 )
Direct Bilirubin: Week 4, n=1,2	0.0000 ( 99999 )	0.0000 ( 0.00000 )
Direct Bilirubin: Week 8, n=1,2	0.0000 ( 99999 )	0.1710 ( 0.24183 )
Direct Bilirubin: Week 12, n=1,2	0.0000 ( 99999 )	0.4275 ( 0.60458 )
Direct Bilirubin: Week 24, n=1,2	0.0000 ( 99999 )	0.4275 ( 0.60458 )
Direct Bilirubin: Week 32, n=1,1	0.0000 ( 99999 )	0.0000 ( 99999 )
Direct Bilirubin: Week 36, n=1,2	0.0000 ( 99999 )	0.0855 ( 0.12092 )
Direct Bilirubin: Week 40, n=1,2	0.0000 ( 99999 )	0.0000 ( 0.00000 )
Direct Bilirubin: Week 48, n=0,2	-88888 ( 88888 )	0.0855 ( 0.12092 )
Direct Bilirubin: Week 52, n=1,2	0.0000 ( 99999 )	0.0855 ( 0.12092 )

Notes
[28] - Safety Set
[29] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameter: Protein

Top of page

End point title

Change from Baseline in clinical chemistry parameter: Protein

End point description

Blood samples were collected to analyze the clinical chemistry parameter: Protein. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[30]	2 ^[31]
Units: Grams per liter
arithmetic mean (standard deviation)
Week 4, n=1,2	6.00 ( 99999 )	-2.30 ( 1.838 )
Week 8, n=1,2	5.00 ( 99999 )	-1.85 ( 1.202 )
Week 12, n=1,2	-1.00 ( 99999 )	-2.65 ( 0.495 )
Week 24, n=1,2	2.00 ( 99999 )	-1.45 ( 2.051 )
Week 32, n=1,1	4.00 ( 99999 )	2.00 ( 99999 )
Week 36, n=1,2	6.00 ( 99999 )	-1.65 ( 3.748 )
Week 40, n=1,2	3.00 ( 99999 )	2.25 ( 5.303 )
Week 48, n=0,2	-88888 ( 88888 )	0.10 ( 2.687 )
Week 52, n=1,2	3.00 ( 99999 )	-0.65 ( 2.333 )

Notes
[30] - Safety Set
[31] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameter: Ferritin

Top of page

End point title

Change from Baseline in clinical chemistry parameter: Ferritin

End point description

Blood samples were collected to analyze the clinical chemistry parameter: Ferritin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[32]	2 ^[33]
Units: micrograms per liter (µg/L)
arithmetic mean (standard deviation)
Week 4, n=1,2	-32.00 ( 99999 )	-12.60 ( 20.365 )
Week 8, n=1,2	167.00 ( 99999 )	-17.30 ( 12.304 )
Week 12, n=1,2	28.00 ( 99999 )	-23.30 ( 19.375 )
Week 16, n=1,2	-29.00 ( 99999 )	-24.95 ( 9.970 )
Week 20, n=1,2	-35.00 ( 99999 )	-28.50 ( 13.435 )
Week 24, n=1,2	-33.00 ( 99999 )	-26.95 ( 22.698 )
Week 28, n=1,2	-36.00 ( 99999 )	-27.65 ( 25.951 )
Week 32, n=1,1	-14.00 ( 99999 )	-22.00 ( 99999 )
Week 36, n=1,2	42.00 ( 99999 )	-31.00 ( 12.728 )
Week 40, n=1,2	42.00 ( 99999 )	-9.60 ( 37.335 )
Week 44, n=1,2	75.00 ( 99999 )	-3.00 ( 59.397 )
Week 48, n=0,2	-88888 ( 88888 )	-16.30 ( 50.487 )
Week 52, n=1,2	39.00 ( 99999 )	-5.05 ( 56.498 )

Notes
[32] - Safety Set
[33] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameter: Transferrin saturation

Top of page

End point title

Change from Baseline in clinical chemistry parameter: Transferrin saturation

End point description

Blood samples were collected to analyze the clinical chemistry parameter: Transferrin saturation. Transferrin saturation is measured as a percentage (%), it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[34]	2 ^[35]
Units: Percentage of transferrin saturation
arithmetic mean (standard deviation)
Week 4, n=1,2	-6.900 ( 99999 )	-14.990 ( 43.8548 )
Week 8, n=1,2	-2.300 ( 99999 )	6.385 ( 7.6155 )
Week 12, n=1,2	6.500 ( 99999 )	-18.245 ( 68.9500 )
Week 16, n=1,2	-0.900 ( 99999 )	-2.775 ( 4.5608 )
Week 20, n=1,2	-3.600 ( 99999 )	-18.500 ( 55.8614 )
Week 24, n=1,2	-7.770 ( 99999 )	-12.995 ( 55.1614 )
Week 28, n=1,2	-6.900 ( 99999 )	-29.050 ( 56.4978 )
Week 32, n=1,1	-8.100 ( 99999 )	-69.000 ( 99999 )
Week 36, n=1,2	3.100 ( 99999 )	-31.620 ( 62.7628 )
Week 40, n=1,2	3.100 ( 99999 )	-32.230 ( 52.0006 )
Week 44, n=1,2	-7.600 ( 99999 )	-27.305 ( 27.8529 )
Week 48, n=0,2	-88888 ( 88888 )	-25.715 ( 28.6873 )
Week 52, n=1,2	-1.500 ( 99999 )	-7.520 ( 51.5905 )

Notes
[34] - Safety Set
[35] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameter: Estimated Glomerular Filtration Rate

Top of page

End point title

Change from Baseline in clinical chemistry parameter: Estimated Glomerular Filtration Rate

End point description

Blood samples were collected to analyze the clinical chemistry parameter: Estimated Glomerular Filtration Rate. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[36]	2 ^[37]
Units: milliliter per minute per 1.73 meter^2
arithmetic mean (standard deviation)
Week 4, n=1,2	-0.380 ( 99999 )	0.615 ( 0.7990 )
Week 8, n=1,2	-2.020 ( 99999 )	-0.310 ( 2.4042 )
Week 12, n=1,2	0.040 ( 99999 )	-1.095 ( 3.0335 )
Week 16, n=1,2	-0.060 ( 99999 )	-1.530 ( 2.0365 )
Week 20, n=1,2	0.440 ( 99999 )	-1.740 ( 0.3253 )
Week 24, n=1,2	0.130 ( 99999 )	-2.655 ( 2.3405 )
Week 28, n=1,2	-0.930 ( 99999 )	-1.200 ( 1.2445 )
Week 32, n=1,1	-1.320 ( 99999 )	-4.650 ( 99999 )
Week 36, n=1,2	-1.460 ( 99999 )	-2.370 ( 5.1053 )
Week 40, n=1,2	-1.580 ( 99999 )	-6.565 ( 4.3346 )
Week 44, n=1,2	-1.770 ( 99999 )	-4.855 ( 4.0800 )
Week 48, n=0,2	-88888 ( 88888 )	-5.410 ( 4.4548 )
Week 52, n=1,2	-2.260 ( 99999 )	-5.935 ( 6.6539 )

Notes
[36] - Safety Set
[37] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameter: Prothrombin International Normalized Ratio

Top of page

End point title

Change from Baseline in clinical chemistry parameter: Prothrombin International Normalized Ratio

End point description

Blood samples were collected to analyze the clinical chemistry parameter: Prothrombin International Normalized Ratio. It is used to assess the clotting ability of blood. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	1 ^[38]	1 ^[39]
Units: Ratio
arithmetic mean (standard deviation)
Week 4, n=1,1	-0.010 ( 99999 )	-0.010 ( 99999 )
Week 8, n=1,1	-0.040 ( 99999 )	0.050 ( 99999 )
Week 12, n=1,1	0.010 ( 99999 )	0.030 ( 99999 )
Week 24, n=1,1	-0.040 ( 99999 )	0.010 ( 99999 )
Week 32, n=1,0	-0.010 ( 99999 )	-88888 ( 88888 )
Week 36, n=1,1	0.010 ( 99999 )	-0.020 ( 99999 )
Week 40, n=1,1	0.030 ( 99999 )	0.010 ( 99999 )
Week 48, n=0,1	-88888 ( 88888 )	-0.010 ( 99999 )
Week 52, n=1,1	0.030 ( 99999 )	0.040 ( 99999 )

Notes
[38] - Safety Set
[39] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)

Top of page

End point title

Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)

End point description

Systolic and Diastolic Blood Pressure readings in millimeters of mercury (mmHg) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[40]	2 ^[41]
Units: millimeters of mercury (mmHg)
arithmetic mean (standard deviation)
SBP: Week 2, n=2,2	11.5 ( 9.19 )	-8.0 ( 11.31 )
SBP: Week 4, n=1,2	9.0 ( 99999 )	3.5 ( 7.78 )
SBP: Week 8, n=1,2	6.0 ( 99999 )	-0.5 ( 16.26 )
SBP: Week 12, n=1,2	0.0 ( 99999 )	-9.5 ( 7.78 )
SBP: Week 16, n=1,2	2.0 ( 99999 )	-8.5 ( 2.12 )
SBP: Week 20, n=1,2	8.0 ( 99999 )	-7.5 ( 9.19 )
SBP: Week 24, n=1,2	25.0 ( 99999 )	-7.0 ( 2.83 )
SBP: Week 28, n=1,2	17.0 ( 99999 )	0.0 ( 19.80 )
SBP: Week 32, n=1,1	20.0 ( 99999 )	20.0 ( 99999 )
SBP: Week 36, n=1,2	16.0 ( 99999 )	2.5 ( 14.85 )
SBP: Week 40, n=1,2	10.0 ( 99999 )	-1.0 ( 28.28 )
SBP: Week 44, n=1,2	7.0 ( 99999 )	-5.5 ( 0.71 )
SBP: Week 48, n=0,2	-88888 ( 88888 )	4.0 ( 29.70 )
SBP: Week 52, n=1,2	4.0 ( 99999 )	0.0 ( 16.97 )
DBP: Week 2, n=2,2	3.5 ( 2.12 )	-7.5 ( 3.54 )
DBP: Week 4, n=1,2	19.0 ( 99999 )	2.5 ( 14.85 )
DBP: Week 8, n=1,2	8.0 ( 99999 )	-3.0 ( 2.83 )
DBP: Week 12, n=1,2	-4.0 ( 99999 )	-1.0 ( 1.41 )
DBP: Week 16, n=1,2	5.0 ( 99999 )	-8.0 ( 0.00 )
DBP: Week 20, n=1,2	4.0 ( 99999 )	-10.0 ( 9.90 )
DBP: Week 24, n=1,2	16.0 ( 99999 )	-4.5 ( 10.61 )
DBP: Week 28, n=1,2	6.0 ( 99999 )	4.0 ( 8.49 )
DBP: Week 32, n=1,1	8.0 ( 99999 )	7.0 ( 99999 )
DBP: Week 36, n=1,2	11.0 ( 99999 )	5.0 ( 4.24 )
DBP: Week 40, n=1,2	2.0 ( 99999 )	0.0 ( 5.66 )
DBP: Week 44, n=1,2	11.0 ( 99999 )	4.5 ( 0.71 )
DBP: Week 48, n=0,2	-88888 ( 88888 )	-2.0 ( 0.00 )
DBP: Week 52, n=1,2	1.0 ( 99999 )	-6.0 ( 1.41 )

Notes
[40] - Safety Set
[41] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in heart rate (HR)

Top of page

End point title

Change from Baseline in heart rate (HR)

End point description

Heart rate readings in beats per minutes (bpm) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[42]	2 ^[43]
Units: beats per minute
arithmetic mean (standard deviation)
Week 2, n=2,2	-12.5 ( 9.19 )	-9.0 ( 4.24 )
Week 4, n=1,2	2.0 ( 99999 )	-2.0 ( 18.38 )
Week 8, n=1,2	15.0 ( 99999 )	-8.0 ( 28.28 )
Week 12, n=1,2	5.0 ( 99999 )	-11.0 ( 43.84 )
Week 16, n=1,2	-10.0 ( 99999 )	-12.0 ( 14.14 )
Week 20, n=1,2	0.0 ( 99999 )	4.0 ( 14.14 )
Week 24, n=1,2	8.0 ( 99999 )	5.5 ( 6.36 )
Week 28, n=1,2	14.0 ( 99999 )	3.0 ( 5.66 )
Week 32, n=1,1	11.0 ( 99999 )	-12.0 ( 99999 )
Week 36, n=1,2	1.00 ( 99999 )	3.5 ( 7.78 )
Week 40, n=1,1	-1.0 ( 99999 )	30.0 ( 99999 )
Week 44, n=1,2	12.0 ( 99999 )	-3.5 ( 12.02 )
Week 48, n=0,2	-88888 ( 88888 )	-17.5 ( 14.85 )
Week 52, n=1,2	-3.0 ( 99999 )	3.0 ( 1.41 )

Notes
[42] - Safety Set
[43] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in weight

Top of page

End point title

Change from Baseline in weight

End point description

Weight readings in kilogram (kg) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[44]	2 ^[45]
Units: kilograms (Kg)
arithmetic mean (standard deviation)
Week 2, n=2,2	-1.00 ( 0.141 )	-0.70 ( 0.566 )
Week 4, n=1,2	-1.80 ( 99999 )	-0.25 ( 1.485 )
Week 8, n=1,2	-2.40 ( 99999 )	0.40 ( 0.141 )
Week 12, n=1,2	1.20 ( 99999 )	1.00 ( 0.566 )
Week 16, n=1,2	-0.50 ( 99999 )	0.60 ( 0.283 )
Week 20, n=1,2	2.20 ( 99999 )	0.70 ( 0.849 )
Week 24, n=1,2	2.00 ( 99999 )	0.45 ( 0.212 )
Week 28, n=1,2	1.70 ( 99999 )	0.80 ( 0.990 )
Week 32, n=1,1	1.00 ( 99999 )	1.90 ( 99999 )
Week 36, n=1,2	0.20 ( 99999 )	0.95 ( 1.768 )
Week 40, n=1,2	0.80 ( 99999 )	0.95 ( 1.061 )
Week 44, n=1,2	1.50 ( 99999 )	1.85 ( 0.495 )
Week 48, n=0,2	-88888 ( 88888 )	2.90 ( 0.000 )
Week 52, n=1,2	1.30 ( 99999 )	2.70 ( 0.000 )

Notes
[44] - Safety Set
[45] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in height

Top of page

End point title

Change from Baseline in height

End point description

Height readings in centimeters (cm) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[46]	2 ^[47]
Units: centimeters (cm)
arithmetic mean (standard deviation)
Week 2, n=2,2	-1.50 ( 2.121 )	0.85 ( 1.202 )
Week 4, n=1,2	0.00 ( 99999 )	0.95 ( 0.495 )
Week 8, n=1,2	0.00 ( 99999 )	1.20 ( 0.707 )
Week 12, n=1,2	0.00 ( 99999 )	2.65 ( 0.071 )
Week 16, n=1,2	0.10 ( 99999 )	1.85 ( 1.485 )
Week 20, n=1,2	0.30 ( 99999 )	3.35 ( 0.495 )
Week 24, n=1,2	0.30 ( 99999 )	3.70 ( 0.707 )
Week 28, n=1,2	1.00 ( 99999 )	4.60 ( 0.141 )
Week 32, n=1,1	0.80 ( 99999 )	5.30 ( 99999 )
Week 36, n=1,2	0.50 ( 99999 )	5.00 ( 1.131 )
Week 40, n=1,2	0.20 ( 99999 )	4.50 ( 2.546 )
Week 44, n=1,2	0.20 ( 99999 )	5.65 ( 2.192 )
Week 48, n=0,2	-88888 ( 88888 )	5.65 ( 2.192 )
Week 52, n=1,2	-0.70 ( 99999 )	6.25 ( 2.333 )

Notes
[46] - Safety Set
[47] - Safety Set

No statistical analyses for this end point

Secondary: Absolute values of hemoglobin (Hgb)

Top of page

End point title

Absolute values of hemoglobin (Hgb)

End point description

Blood samples were collected from all participants for measurement of Hgb values in grams per deciliter (g/dL). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Hgb results of a single participant of both the arms from Week 8 to Week 52 (for participants requiring Dialysis) and from Week 40 to Week 52 (for participants not requiring Dialysis) were excluded from summary due to intercurrent events. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[48]	2 ^[49]
Units: grams per deciliter
arithmetic mean (standard deviation)
Baseline (Day 1), n=2,2	11.00 ( 0.424 )	11.35 ( 0.919 )
Week 2, n=2,2	10.85 ( 1.061 )	11.90 ( 0.990 )
Week 4, n=1,2	11.80 ( 99999 )	11.50 ( 0.566 )
Week 8, n=0,2	-88888 ( 88888 )	11.65 ( 0.212 )
Week 12, n=0,2	-88888 ( 88888 )	11.80 ( 0.283 )
Week 16, n=0,2	-88888 ( 88888 )	10.95 ( 0.495 )
Week 20, n=0,2	-88888 ( 88888 )	11.55 ( 0.212 )
Week 24, n=0,2	-88888 ( 88888 )	11.70 ( 0.141 )
Week 28, n=0,2	-88888 ( 88888 )	11.65 ( 0.354 )
Week 32, n=0,1	-88888 ( 88888 )	11.80 ( 99999 )
Week 36, n=0,2	-88888 ( 88888 )	11.95 ( 0.354 )
Week 40, n=0,1	-88888 ( 88888 )	12.10 ( 99999 )
Week 44, n=0,1	-88888 ( 88888 )	11.20 ( 99999 )
Week 48, n=0,1	-88888 ( 88888 )	11.90 ( 99999 )
Week 52, n=0,1	-88888 ( 88888 )	12.60 ( 99999 )

Notes
[48] - Safety Set
[49] - Safety Set

No statistical analyses for this end point

Secondary: Change from Baseline in hemoglobin (Hgb)

Top of page

End point title

Change from Baseline in hemoglobin (Hgb)

End point description

Blood samples were collected from all participants for measurement of Hgb values in g/dL. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Hgb results of a single participant of both the arms from Week 8 to Week 52 (for participants requiring Dialysis) and from Week 40 to Week 52 (for participants not requiring Dialysis) were excluded from summary due to intercurrent events. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[50]	2 ^[51]
Units: grams per Liter
arithmetic mean (standard deviation)
Week 2, n=2,2	-0.15 ( 0.636 )	0.55 ( 0.071 )
Week 4, n=1,2	0.5 ( 99999 )	0.15 ( 1.485 )
Week 8, n=0,2	-88888 ( 88888 )	0.30 ( 1.131 )
Week 12, n=0,2	-88888 ( 88888 )	0.45 ( 0.636 )
Week 16, n=0,2	-88888 ( 88888 )	-0.40 ( 1.414 )
Week 20, n=0,2	-88888 ( 88888 )	0.20 ( 0.707 )
Week 24, n=0,2	-88888 ( 88888 )	0.35 ( 1.061 )
Week 28, n=0,2	-88888 ( 88888 )	0.30 ( 1.273 )
Week 32, n=0,1	-88888 ( 88888 )	1.10 ( 99999 )
Week 36, n=0,2	-88888 ( 88888 )	0.60 ( 0.566 )
Week 40, n=0,1	-88888 ( 88888 )	0.10 ( 99999 )
Week 44, n=0,1	-88888 ( 88888 )	-0.80 ( 99999 )
Week 48, n=0,1	-88888 ( 88888 )	-0.10 ( 99999 )
Week 52, n=0,1	-88888 ( 88888 )	0.60 ( 99999 )

Notes
[50] - Safety Set
[51] - Safety Set

No statistical analyses for this end point

Secondary: Number of participants with Hgb values above, below and within the target range (10 to 12 g/dL)

Top of page

End point title

Number of participants with Hgb values above, below and within the target range (10 to 12 g/dL)

End point description

Number of participants with Hgb values above, below, and within the target range (10 to 12 g/dL) were assessed. Baseline assessment was defined as the last non-missing value prior to the start date and time of the study drug (Day 1). Hgb results of a single participant of both the arms from Week 8 to Week 52 (for participants requiring Dialysis) and from Week 40 to Week 52 (for participants not requiring Dialysis) were excluded from summary due to intercurrent events. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[52]	2 ^[53]
Units: Participants
Baseline (Day 1): Above Target Range, n=2,2	0	0
Week 2: Above Target Range, n=2,2	0	1
Week 4: Above Target Range, n=1,2	0	0
Week 8: Above Target Range, n=0,2	0	0
Week 12: Above Target Range, n=0,2	0	0
Week 16: Above Target Range, n=0,2	0	0
Week 20: Above Target Range, n=0,2	0	0
Week 24: Above Target Range, n=0,2	0	0
Week 28: Above Target Range, n=0,2	0	0
Week 32: Above Target Range, n=0,1	0	0
Week 36: Above Target Range, n=0,2	0	1
Week 40: Above Target Range, n=0,1	0	1
Week 44: Above Target Range, n=0,1	0	0
Week 48: Above Target Range, n=0,1	0	0
Week 52: Above Target Range, n=0,1	0	1
Baseline (Day 1): Within Target Range, n=2,2	2	2
Week 2: Within Target Range, n=2,2	2	1
Week 4: Within Target Range, n=1,2	1	2
Week 8: Within Target Range, n=0,2	0	2
Week 12: Within Target Range, n=0,2	0	2
Week 16: Within Target Range, n=0,2	0	2
Week 20: Within Target Range, n=0,2	0	2
Week 24: Within Target Range, n=0,2	0	2
Week 28: Within Target Range, n=0,2	0	2
Week 32: Within Target Range, n=0,1	0	1
Week 36: Within Target Range, n=0,2	0	1
Week 40: Within Target Range, n=0,1	0	0
Week 44: Within Target Range, n=0,1	0	1
Week 48: Within Target Range, n=0,1	0	1
Week 52: Within Target Range, n=0,1	0	0
Baseline (Day 1): Below Target Range, n=2,2	0	0
Week 2: Below Target Range, n=2,2	0	0
Week 4: Below Target Range, n=1,2	0	0
Week 8: Below Target Range, n=0,2	0	0
Week 12: Below Target Range, n=0,2	0	0
Week 16: Below Target Range, n=0,2	0	0
Week 20: Below Target Range, n=0,2	0	0
Week 24: Below Target Range, n=0,2	0	0
Week 28: Below Target Range, n=0,2	0	0
Week 32: Below Target Range, n=0,1	0	0
Week 36: Below Target Range, n=0,2	0	0
Week 40: Below Target Range, n=0,1	0	0
Week 44: Below Target Range, n=0,1	0	0
Week 48: Below Target Range, n=0,1	0	0
Week 52: Below Target Range, n=0,1	0	0

Notes
[52] - Safety Set
[53] - Safety Set

No statistical analyses for this end point

Secondary: Change in Daprodustat dose from starting dose at each study time point

Top of page

End point title

Change in Daprodustat dose from starting dose at each study time point

End point description

Daprodustat dose was adjusted during the study based on participant’s Hgb levels. Dose change values of daprodustat from starting dose at each study time point were calculated as dose level at indicated time point minus starting dose at Day 1. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant. 88888 indicates data is not available.

End point type

Secondary

End point timeframe

Day 1, at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[54]	2 ^[55]
Units: milligrams
arithmetic mean (standard deviation)
Week 2, n=2,2	0 ( 0 )	-1 ( 1.41 )
Week 4, n=1,2	0 ( 99999 )	-0.5 ( 0.71 )
Week 8, n=1,2	-6 ( 99999 )	-0.5 ( 0.71 )
Week 12, n=1,2	-2 ( 99999 )	-0.5 ( 0.71 )
Week 16, n=1,2	0 ( 99999 )	-0.5 ( 0.71 )
Week 20, n=1,2	0 ( 99999 )	-0.5 ( 0.71 )
Week 24, n=1,2	0 ( 99999 )	-0.5 ( 0.71 )
Week 28, n=1,2	-2 ( 99999 )	-0.5 ( 0.71 )
Week 32, n=1,1	-6 ( 99999 )	0 ( 99999 )
Week 36, n=1,2	-4 ( 99999 )	-1 ( 1.41 )
Week 40, n=1,2	-4 ( 99999 )	-2 ( 0 )
Week 44, n=1,2	-4 ( 99999 )	-1 ( 0 )
Week 48, n=0,2	-88888 ( 88888 )	-1 ( 99999 )

Notes
[54] - Safety Set
[55] - Safety Set

No statistical analyses for this end point

Secondary: Number of participants with 0 to 10, or greater than (>) 10 dose adjustments

Top of page

End point title

Number of participants with 0 to 10, or greater than (>) 10 dose adjustments

End point description

Number of participants who required dapurodustat dose adjustments form the starting dose were assessed. Data was categorized for number of participants who required no dose change (0 times) to 10 times and >10times dose adjustments during the study. Safety Set.

End point type

Secondary

End point timeframe

Up to Week 52

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[56]	2 ^[57]
Units: Participants
No dose change (0 time)	1	0
1 time	0	0
2 times	0	1
3 times	0	0
4 times	0	0
5 times	0	0
6 times	1	1
7 times	0	0
8 times	0	0
9 times	0	0
10 times	0	0
>10 times	0	0

Notes
[56] - Safety Set
[57] - Safety Set

No statistical analyses for this end point

Secondary: Daprodustat Dose at each study time point

Top of page

End point title

Daprodustat Dose at each study time point

End point description

Mean and standard deviation of Daprodustat Dose received by participants at each study time point has been presented. Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in category titles). 99999 indicates that standard deviation could not be calculated for single participant.

End point type

Secondary

End point timeframe

Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[58]	2 ^[59]
Units: milligrams
arithmetic mean (standard deviation)
Baseline (Day 1), n=2,2	6.0 ( 0.0000 )	2.0 ( 0.00 )
Week 2, n=2,2	6.0 ( 0.0000 )	1.0 ( 1.41 )
Week 4, n=1,2	6.0 ( 99999 )	1.5 ( 0.71 )
Week 8, n=1,2	0.0 ( 99999 )	1.5 ( 0.71 )
Week 12, n=1,2	4.0 ( 99999 )	1.5 ( 0.71 )
Week 16, n=1,2	6.0 ( 99999 )	1.5 ( 0.71 )
Week 20, n=1,2	6.0 ( 99999 )	1.5 ( 0.71 )
Week 24, n=1,2	6.00 ( 99999 )	1.5 ( 0.71 )
Week 28, n=1,2	4.0 ( 99999 )	1.5 ( 0.71 )
Week 32, n=1,1	0.0 ( 99999 )	2.0 ( 99999 )
Week 36, n=1,2	2.0 ( 99999 )	1.0 ( 1.41 )
Week 40, n=1,2	2.0 ( 99999 )	0.0 ( 0.00 )
Week 44, n=1,2	2.0 ( 99999 )	1.0 ( 0.00 )
Week 48, n=0,1	-88888 ( 88888 )	1.0 ( 99999 )

Notes
[58] - Safety Set
[59] - Safety Set

No statistical analyses for this end point

Secondary: Maximum plasma concentration (Cmax) of daprodustat

Top of page

End point title

Maximum plasma concentration (Cmax) of daprodustat

End point description

Blood samples were collected for the plasma concentrations of daprodustat from which pharmacokinetic (PK) parameters were determined. Mean and standard deviation of daprodustat Cmax at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). The analysis was performed on the All Pharmacokinetic Set that included all participants in the Safety analysis who had at least 1 non-missing PK assessment (non-quantifiable values will be considered as non-missing values).

End point type

Secondary

End point timeframe

Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dose

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[60]	2 ^[61]
Units: Nanograms per milliliters (ng/mL)
arithmetic mean (standard deviation)	115.047 ( 3.854 )	19.447 ( 10.770 )

Notes
[60] - All Pharmacokinetic Set
[61] - All Pharmacokinetic Set

No statistical analyses for this end point

Secondary: Area under the curve (AUC) at steady state of daprodustat

Top of page

End point title

Area under the curve (AUC) at steady state of daprodustat

End point description

Blood samples were collected for the plasma concentrations of daprodustat from which PK parameters were determined. Mean and standard deviation of daprodustat AUC at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). All Pharmacokinetic Set.

End point type

Secondary

End point timeframe

Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dose

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[62]	2 ^[63]
Units: Hoursnanogram per milliliter (hng/mL)
arithmetic mean (standard deviation)	185.379 ( 8.661 )	56.634 ( 6.009 )

Notes
[62] - All Pharmacokinetic Set
[63] - All Pharmacokinetic Set

No statistical analyses for this end point

Secondary: Plasma concentrations of daprodustat and metabolites at pre-dose (Ctrough)

Top of page

End point title

Plasma concentrations of daprodustat and metabolites at pre-dose (Ctrough)

End point description

Blood samples were collected for the plasma concentrations of daprodustat and metabolites from which PK parameters were determined. Mean and standard deviation of raw daprodustat and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401) at steady state at pre-dose obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). All Pharmacokinetic Set. 99999 indicates that data could not be calculated as the concentration values were below the lower limit of quantification. 88888 indicates standard deviation could not be calculated as a single participant was analyzed.

End point type

Secondary

End point timeframe

Pre-dose on Week 2

End point values	Participants requiring Dialysis (D)	Participants not yet requiring Dialysis (ND)
Number of subjects analysed	2 ^[64]	2 ^[65]
Units: Nanograms per milliliters (ng/mL)
arithmetic mean (standard deviation)
Daprodustat	0.4995 ( 0.3698 )	99999 ( 99999 )
GSK2391220	6.540 ( 2.206 )	99999 ( 99999 )
GSK2487818	0.869 ( 0.137 )	99999 ( 99999 )
GSK2506102	3.040 ( 0.424 )	99999 ( 99999 )
GSK2506104	10.55 ( 3.18 )	0.143 ( 88888 )
GSK2531398	2.490 ( 0.184 )	99999 ( 99999 )
GSK2531401	11.25 ( 1.48 )	0.127 ( 88888 )

Notes
[64] - All Pharmacokinetic Set
[65] - All Pharmacokinetic Set

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.

Adverse event reporting additional description

All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

27.1

Reporting group title

Participants not yet requiring Dialysis (ND)

Reporting group description

Reporting group title

Participants requiring Dialysis (D)

Reporting group description

Serious adverse events	Participants not yet requiring Dialysis (ND)	Participants requiring Dialysis (D)
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events
Congenital, familial and genetic disorders
Congenital uterine anomaly
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Retroperitoneal haematoma
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Participants not yet requiring Dialysis (ND)	Participants requiring Dialysis (D)
Total subjects affected by non serious adverse events
subjects affected / exposed	2 / 2 (100.00%)	2 / 2 (100.00%)
Investigations
Serum ferritin increased
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	1
Injury, poisoning and procedural complications
Foot fracture
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)
occurrences all number	1	0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)
occurrences all number	2	0
COVID-19
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)
occurrences all number	1	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

22 Jun 2022

Amendment 01: The primary rationale for Amendment 01 is to add the requirement for a temporary dose hold if the hemoglobin (Hgb) at Week 2 is greater than 12.5 g/dL. Additional changes are to provide further clarity of study requirements and to address regulatory feedback.

18 Nov 2022

Amendment 02: The primary rationale for Amendment 02 is to include heart failure (HF) and esophageal/gastric erosions as adverse events of special interest (AESIs) following recent review of the clinical trial data in the adult daprodustat global development program.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
16 May 2024	Pause in recruitment. Recruitment was never restarted.	-

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

As the study was terminated early, only one age group 12 to <18 years of age was recruited as per the study design. As a result of low enrollment in study, no meaningful conclusions with respect to primary and secondary objectives could be reached.

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated with Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of participants with any adverse events (AEs) and serious adverse events (SAEs)

Primary: Number of participants with any adverse events (AEs) and serious adverse events (SAEs)

Primary: Number of participants with adverse event of special interests (AESIs)

Primary: Number of participants with adverse event of special interests (AESIs)

Primary: Number of participants with AEs leading to study intervention discontinuation

Primary: Number of participants with AEs leading to study intervention discontinuation

Secondary: Change from Baseline in hematology parameter: Hematocrit

Secondary: Change from Baseline in hematology parameter: Hematocrit

Secondary: Change from Baseline in hematology parameter: Reticulocytes/Erythrocytes

Secondary: Change from Baseline in hematology parameter: Reticulocytes/Erythrocytes

Secondary: Change from Baseline in hematology parameter: Erythrocytes

Secondary: Change from Baseline in hematology parameter: Erythrocytes

Secondary: Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count

Secondary: Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count

Secondary: Change from Baseline in hematology parameter: Erythrocytes Mean Corpuscular Volume

Secondary: Change from Baseline in hematology parameter: Erythrocytes Mean Corpuscular Volume

Secondary: Change from Baseline in hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin

Secondary: Change from Baseline in hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin

Secondary: Change from Baseline in clinical chemistry parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)

Secondary: Change from Baseline in clinical chemistry parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)

Secondary: Change from Baseline in clinical chemistry parameter: Creatinine

Secondary: Change from Baseline in clinical chemistry parameter: Creatinine

Secondary: Change from Baseline in clinical chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

Secondary: Change from Baseline in clinical chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

Secondary: Change from Baseline in clinical chemistry parameters: Bilirubin and Direct Bilirubin

Secondary: Change from Baseline in clinical chemistry parameters: Bilirubin and Direct Bilirubin

Secondary: Change from Baseline in clinical chemistry parameter: Protein

Secondary: Change from Baseline in clinical chemistry parameter: Protein

Secondary: Change from Baseline in clinical chemistry parameter: Ferritin

Secondary: Change from Baseline in clinical chemistry parameter: Ferritin

Secondary: Change from Baseline in clinical chemistry parameter: Transferrin saturation

Secondary: Change from Baseline in clinical chemistry parameter: Transferrin saturation

Secondary: Change from Baseline in clinical chemistry parameter: Estimated Glomerular Filtration Rate

Secondary: Change from Baseline in clinical chemistry parameter: Estimated Glomerular Filtration Rate

Secondary: Change from Baseline in clinical chemistry parameter: Prothrombin International Normalized Ratio

Secondary: Change from Baseline in clinical chemistry parameter: Prothrombin International Normalized Ratio

Secondary: Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)

Secondary: Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)

Secondary: Change from Baseline in heart rate (HR)

Secondary: Change from Baseline in heart rate (HR)

Secondary: Change from Baseline in weight

Secondary: Change from Baseline in weight

Secondary: Change from Baseline in height

Secondary: Change from Baseline in height

Secondary: Absolute values of hemoglobin (Hgb)

Secondary: Absolute values of hemoglobin (Hgb)

Secondary: Change from Baseline in hemoglobin (Hgb)

Secondary: Change from Baseline in hemoglobin (Hgb)

Secondary: Number of participants with Hgb values above, below and within the target range (10 to 12 g/dL)

Secondary: Number of participants with Hgb values above, below and within the target range (10 to 12 g/dL)

Secondary: Change in Daprodustat dose from starting dose at each study time point

Secondary: Change in Daprodustat dose from starting dose at each study time point

Secondary: Number of participants with 0 to 10, or greater than (>) 10 dose adjustments

Secondary: Number of participants with 0 to 10, or greater than (>) 10 dose adjustments

Secondary: Daprodustat Dose at each study time point

Secondary: Daprodustat Dose at each study time point

Secondary: Maximum plasma concentration (Cmax) of daprodustat

Secondary: Maximum plasma concentration (Cmax) of daprodustat

Secondary: Area under the curve (AUC) at steady state of daprodustat

Secondary: Area under the curve (AUC) at steady state of daprodustat

Secondary: Plasma concentrations of daprodustat and metabolites at pre-dose (Ctrough)

Secondary: Plasma concentrations of daprodustat and metabolites at pre-dose (Ctrough)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated with Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis