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    Clinical Trial Results:
    A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study Evaluating the Safety and Efficacy of Oral GKT137831 in Patients with Type 2 Diabetes and Albuminuria

    Summary
    EudraCT number
    		 2013-002507-34
    Trial protocol
    		 DE   CZ   PL  
    Global end of trial date
    30 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2022
    First version publication date
    20 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GSN000200
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02010242
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Genkyotex SA
    Sponsor organisation address
    16 ch des Aulx, Plan les Ouates, Switzerland, 1228
    Public contact
    Dr Richard Philipson, Calliditas Therapeutics Suisse SA, +46 556659-9766, richard.philipson@calliditas.com
    Scientific contact
    Philippe Wiesel, Genkyotex SA, +33 (0) 4 56 44 81 12, philippe.wiesel@genkyotex.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of oral GKT137831 in comparison with placebo, in patients with type 2 diabetes and albuminuria.
    Protection of trial subjects
    In order to ensure patient safety, a SMB will conduct periodic, scheduled reviews of patient data while the study is in progress. The role and responsibilities of the SMB will be outlined in detail in a separate SMB charter. The SMB will receive unblinded eCRF and laboratory data in the form of tables and listings, and adjudicate on patient status changes and dosing decisions (where appropriate). The data will include, but is not limited to, demographics, patient enrolment, baseline characteristics, AE data, SAE data (by severity and causality), laboratory data including PK, dose adjustments, protocol adherence, and patient withdrawals. The SMB will evaluate the progress of the study, assess data quality and timeliness, participant recruitment, accrual and retention, and participant risk versus benefit. In addition the SMB will monitor external factors relevant to the study, for example scientific and therapeutic developments that may affect participant safety or ethical status. Based on the observed benefits or adverse effects, the SMB will make recommendations to the Sponsor concerning continuation, termination or modifications of the study. In case an absolute reticulocyte count decreases to <50% of the baseline value (defined as the average of the 3 values measured during Visits 3, 4 and 5), the Investigator will instruct the patient to interrupt treatment and to return to the study center within 7 days to perfom a retest. If the retest value is also below 50% of baseline, treatment will not be resumed. Treatment can be resumed only if the retest value for the reticulocyte count is •50% of the baseline value.
    Background therapy
    		 Patients are required to take the following concomitant medications: Patients must be taking an ACEI or an ARB for at least 6 weeks prior to the first screening visit (Visit 1) and during the screening period in order to enter the run-in period. The dose must have been stable for at least 4 weeks prior to the first screening visit (Visit 1). Combination therapy associating an ACEI and an ARB is not permitted. During the run-in period, the dose of ACEI or ARB must be adjusted to the maximal tolerated dose. The dose of ACEI, ARB, and other antihypertensive therapy should remain stable following the second visit of the run-in period, Week -2 (Visit 4), and during the double-blind treatment period.
    Evidence for comparator
    		 N.A
    Actual start date of recruitment
    16 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 16
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Poland: 13
    Country: Number of subjects enrolled
    Czechia: 21
    Country: Number of subjects enrolled
    United States: 56
    Country: Number of subjects enrolled
    Canada: 21
    Worldwide total number of subjects
    136
    EEA total number of subjects
    43
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    81
    From 65 to 84 years
    55
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First Subject enrolled: 18 MARCH 2014 Last subject completed: 19 MARCH 2015

    Pre-assignment
    Screening details
    		 Male or female aged 18 to 80 years, complied with the requirements of the study; history of type 2 diabetes, stratified by presence or absence of impaired renal function, receiving a stable dose of ACEI or ARB, who met all the inclusion criteria and none of the exclusion criteria.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    This is a double-blind study: the Sponsor, subjects, investigator staff, persons performing the assessments and data reviewers and statisticians will remain blinded to the identity of the study treatments. The identity of the study treatments will be concealed by the use of IMPs which are all identical in packaging, labelling, schedule of administration, appearance and odour. Randomization data will be kept strictly confidential, and will be accessible only to authorized personnel.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 A 12-week period of treatment with oral GKT137831
    Arm description
    		 Patients will self-administer orally, 100 mg GKT137831 twice daily for the first 6 weeks (Days 1 to 41), and 200 mg GKT137831 twice daily for the remaining 6 weeks (Days 42 to 84).
    Arm type
    		 Experimental

    Investigational medicinal product name
    GKT137831
    Investigational medicinal product code
    Other name
    setanaxib
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    During the first 6-week period patients will self-administer 1 capsule of 100 mg GKT137831 in the morning, and 1 capsule of 100 mg GKT137831 in the evening, and during the second 6-week period patients will self-administer 2 capsules of 100 mg GKT137831 in the morning, and 2 capsules of 100 mg GKT137831 in the evening.

    Arm title
    		 Placebo
    Arm description
    		 Placebo twice daily administration. Patients will self-administer orally, 100 mg matching placebo twice daily for the first 6 weeks (Days 1 to 41), and 200 mg matching placebo twice daily for the remaining 6 weeks (Days 42 to 84).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Placebo
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    During the first 6-week period patients will self-administer 1 capsule of 100 mg matching placebo in the morning, and 1 capsule of 100 mg matching placebo in the evening, and during the second 6-week period patients will self-administer 2 capsules of 100 mg matching placebo in the morning, and 2 capsules of 100 mg matching placebo in the evening.

    Number of subjects in period 1
    		A 12-week period of treatment with oral GKT137831 Placebo
    Started
    68
    68
    Completed
    64
    61
    Not completed
    4
    7
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    1
    2
         non-compliance with study drug
    1
    1
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    A 12-week period of treatment with oral GKT137831
    Reporting group description
    		 Patients will self-administer orally, 100 mg GKT137831 twice daily for the first 6 weeks (Days 1 to 41), and 200 mg GKT137831 twice daily for the remaining 6 weeks (Days 42 to 84).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo twice daily administration. Patients will self-administer orally, 100 mg matching placebo twice daily for the first 6 weeks (Days 1 to 41), and 200 mg matching placebo twice daily for the remaining 6 weeks (Days 42 to 84).

    Reporting group values
    		 A 12-week period of treatment with oral GKT137831 Placebo Total
    Number of subjects
    		 68 68 136
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 38 43 81
        From 65-84 years
    		 30 25 55
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.1 ± 8.64 62.2 ± 9.9 -
    Gender categorical
    Units: Subjects
        Female
    		 16 16 32
        Male
    		 52 52 104

    End points

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    End points reporting groups
    Reporting group title
    A 12-week period of treatment with oral GKT137831
    Reporting group description
    		 Patients will self-administer orally, 100 mg GKT137831 twice daily for the first 6 weeks (Days 1 to 41), and 200 mg GKT137831 twice daily for the remaining 6 weeks (Days 42 to 84).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo twice daily administration. Patients will self-administer orally, 100 mg matching placebo twice daily for the first 6 weeks (Days 1 to 41), and 200 mg matching placebo twice daily for the remaining 6 weeks (Days 42 to 84).

    Primary: UACR Absolute value and ratio to baseline by study visit and Treatment group

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    End point title
    		 UACR Absolute value and ratio to baseline by study visit and Treatment group
    End point description
    UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively). Baseline for UACR is defined as the geometric mean of the geometric means of the UACR values measured on Day-14 (visit 4) and Day 1 (visit 5). End of treatment is defined as the geometric mean of the geometric means of the UACR values measured at week 8 (visit 9), week 10 (visit 10) and week 12 (visit 11). Number of subjects in the ITT population who have evaluable results
    End point type
    Primary
    End point timeframe
    Visit 4 (week -2) to visit 11 (week 12)
    End point values
    		 A 12-week period of treatment with oral GKT137831 Placebo
    Number of subjects analysed
    62
    59
    Units: mg/g
    geometric mean (confidence interval 90%)
        Baseline Geometric Mean
    705.72 (637.07 to 774.36)
    696.30 (611.98 to 780.61)
        Adjusted End of treatment Geom. Mean
    758.22 (695.61 to 826.46)
    705.29 (646.19 to 769.80)
        Mean for ratio of end of Ttmt v.s baseline
    1.10 (1.01 to 1.20)
    1.02 (0.94 to 1.11)
    Statistical analysis title
    		 Analysis in UACR from baseline by Visit/Treatment
    Statistical analysis description
    Primary efficacy endpoint was analyzed using ANCOVA comparing GKT137831 vs placebo after controlling for the baseline UACR level. The UACR were log-transformed prior to analysis. The model included treatment group and log-transformed baseline UACR value as predicted variables. The results were back-transformed exponentially to calculate geo. mean values and associated 90% CIs and 1-sided p-values. The null hypothesis was that the difference in the adjusted mean logarithm of UACR was equal to 0.
    Comparison groups
    Placebo v A 12-week period of treatment with oral GKT137831
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 1 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 90%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [1] - All statistical analyses were performed on a comparison-wise basis without adjustment for multiple comparisons.
    [2] - No difference observed between arms from baseline

    Secondary: Glucose metabolism HOMA

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    End point title
    		 Glucose metabolism HOMA
    End point description
    Change in HOMA-B, HOMA-IR from baseline. Number of subjects in the ITT population who have evaluable results
    End point type
    Secondary
    End point timeframe
    Visits 5 (week 0), 8 (week 6) and 11 (week 12)
    End point values
    		 A 12-week period of treatment with oral GKT137831 Placebo
    Number of subjects analysed
    10
    10
    Units: mg/dL
    arithmetic mean (standard deviation)
        HOMA-IR W6 change from baseline
    0.916 ± 2.84
    2.013 ± 1.943
        HOMA-IR W12 change from baseline
    0.344 ± 2.32
    -1.833 ± 3.95
        HOMA-B W6 change from baseline
    12.94 ± 24.06
    50.10 ± 75.81
        HOMA-B W12 change from baseline
    -12.41 ± 38.72
    47.63 ± 120.18
    No statistical analyses for this end point

    Secondary: Glucose metabolism HbA1c

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    End point title
    		 Glucose metabolism HbA1c
    End point description
    Change in HbA1c from baseline. Number of subjects in the ITT population who have evaluable results
    End point type
    Secondary
    End point timeframe
    Visits 5 (week0), 8 (week 6) and 11 (week 12)
    End point values
    		 A 12-week period of treatment with oral GKT137831 Placebo
    Number of subjects analysed
    68
    68
    Units: percentage of glycated haemoglobin
    arithmetic mean (standard deviation)
        W6 change from baseline
    0.02 ± 0.538
    -0.03 ± 0.618
        W12 change from baseline
    0.12 ± 0.659
    0.03 ± 0.722
    No statistical analyses for this end point

    Secondary: Change in 24h Albumin excretion

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    End point title
    		 Change in 24h Albumin excretion
    End point description
    Change in 24hours Albumin excretion from baseline. Number of subjects analyzed in the ITT population who have evaluable results
    End point type
    Secondary
    End point timeframe
    Visits 5 (week 0) and 11 (week 12)
    End point values
    		 A 12-week period of treatment with oral GKT137831 Placebo
    Number of subjects analysed
    67
    68
    Units: mg/24hrs
        arithmetic mean (standard deviation)
    389.82 ± 1540.30
    -56.15 ± 1569.23
    No statistical analyses for this end point

    Secondary: Change in 24h urine UACR from baseline

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    End point title
    		 Change in 24h urine UACR from baseline
    End point description
    Change in 24 hours Urine UACR from baseline. Number of subjects analyzed in the IIT population who have evaluable results
    End point type
    Secondary
    End point timeframe
    Visits 5 (week 0) and 11 (week 12)
    End point values
    		 A 12-week period of treatment with oral GKT137831 Placebo
    Number of subjects analysed
    67
    68
    Units: mg/g
        arithmetic mean (standard deviation)
    220.15 ± 592.995
    169.98 ± 706.38
    No statistical analyses for this end point

    Secondary: eGFR change by study visit

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    End point title
    		 eGFR change by study visit
    End point description
    Change in eGFR from baseline by study visit. Number of subjects analyzed in the ITT population who have evaluable results
    End point type
    Secondary
    End point timeframe
    Visits 5 (week 0), 6 (week 2), 7 (week 4), 8 (week 6), 9 (week 8), 10 (week 10), 11 (week 12) , follow up (week 16)
    End point values
    		 A 12-week period of treatment with oral GKT137831 Placebo
    Number of subjects analysed
    68
    68
    Units: mL/min/SSA
    arithmetic mean (standard deviation)
        Change in week2 (V6) eGFR from baseline
    -0.5 ± 6.07
    -0.4 ± 7.27
        Change in week 4 (V7) eGFR from baseline
    -0.6 ± 8.25
    -1.5 ± 6.55
        Change in week 6 (V8) eGFR from baseline
    -0.1 ± 8.13
    -0.3 ± 6.8
        Change in week 8 (V9) eGFR from baseline
    -1.1 ± 8.7
    -1.7 ± 7.31
        Change in week 10 (V10) eGFR from baseline
    -0.7 ± 8.21
    -1.9 ± 7.89
        Change in week 12 (V11) eGFR from baseline
    -1.5 ± 8.28
    -1.2 ± 8.08
        Change in week 16 (follow up) eGFR from baseline
    -1.3 ± 8.21
    -1.9 ± 10.45
    No statistical analyses for this end point

    Secondary: Erectile dysfunction

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    End point title
    		 Erectile dysfunction
    End point description
    Changes at week 12 in IEFF questionnaire assessing erectile dysfunction in patients presenting with these diabetic complications at baseline (Baseline <=25 in the erectile function domain)- Score from 1 to 30. Score 1 to 10: severe erectile dysfunction, Score 11-16: moderate erectile dysfunction, Score 17-25: light erectile dysfunction, Score 26-30:normal erectile function Number of subjects analyzed in the ITT population who have evaluable results.
    End point type
    Secondary
    End point timeframe
    Visits 5 (week 0), and 11 (week 12)
    End point values
    		 A 12-week period of treatment with oral GKT137831 Placebo
    Number of subjects analysed
    46
    45
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.8 ± 5.86
    -0.5 ± 5.06
    No statistical analyses for this end point

    Secondary: Neuropathic pain

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    End point title
    		 Neuropathic pain
    End point description
    Changes in Visual Analog Scale (VAS) assessing neuropathic leg pain in patients presenting with these diabetic complications at baseline (subjects with a baseline VAS>=20mm are included) - 100mm VAS scale was used- Presence of neuropathic pain for a score of at least 20mm. Number of subjects analyzed in the ITT population who have evaluable results.
    End point type
    Secondary
    End point timeframe
    Visits 5 (week 0), and 11 (week 12)
    End point values
    		 A 12-week period of treatment with oral GKT137831 Placebo
    Number of subjects analysed
    31
    31
    Units: score on a scale
        arithmetic mean (standard deviation)
    -15.3 ± 21.79
    -10.5 ± 22.18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 9-10 months
    Adverse event reporting additional description
    Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow up period after the last administration of IMP
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    A 12-week period of treatment with oral GKT137831
    Reporting group description
    		 Patients will self-administer orally, 100 mg GKT137831 twice daily for the first 6 weeks (Days 1 to 41), and 200 mg GKT137831 twice daily for the remaining 6 weeks (Days 42 to 84).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo twice daily administration. Patients will self-administer orally, 100 mg matching placebo twice daily for the first 6 weeks (Days 1 to 41), and 200 mg matching placebo twice daily for the remaining 6 weeks (Days 42 to 84).

    Serious adverse events
    		 A 12-week period of treatment with oral GKT137831 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 68 (4.41%)
    5 / 68 (7.35%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Small cell lung cancer
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure acute
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoglycemic encephalopathy
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non cardiac chest pain
         subjects affected / exposed
    1 / 68 (1.47%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lobular Pneumonia
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract inifection
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycemia
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 A 12-week period of treatment with oral GKT137831 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 68 (48.53%)
    42 / 68 (61.76%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 68 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Edema peripheral
         subjects affected / exposed
    2 / 68 (2.94%)
    6 / 68 (8.82%)
         occurrences all number
    2
    6
    Fatigue
         subjects affected / exposed
    0 / 68 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    0
    2
    Non cardiac chest pain
         subjects affected / exposed
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences all number
    1
    3
    Respiratory, thoracic and mediastinal disorders
    Respiratory, Thoracic disorders
         subjects affected / exposed
    2 / 68 (2.94%)
    3 / 68 (4.41%)
         occurrences all number
    2
    5
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    3
    Investigations
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 68 (1.47%)
    2 / 68 (2.94%)
         occurrences all number
    1
    2
    Injury, poisoning and procedural complications
    Limb Injury
         subjects affected / exposed
    2 / 68 (2.94%)
    1 / 68 (1.47%)
         occurrences all number
    2
    1
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    1 / 68 (1.47%)
    4 / 68 (5.88%)
         occurrences all number
    1
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences all number
    1
    3
    Headache
         subjects affected / exposed
    2 / 68 (2.94%)
    2 / 68 (2.94%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences all number
    2
    0
    Diarrhea
         subjects affected / exposed
    3 / 68 (4.41%)
    4 / 68 (5.88%)
         occurrences all number
    3
    5
    Nausea
         subjects affected / exposed
    0 / 68 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    2 / 68 (2.94%)
    1 / 68 (1.47%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Anthralgia
         subjects affected / exposed
    0 / 68 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    0
    2
    Back pain
         subjects affected / exposed
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences all number
    1
    4
    Myalgia
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences all number
    2
    0
    Pain in extremity
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 68 (2.94%)
    2 / 68 (2.94%)
         occurrences all number
    2
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 68 (2.94%)
    2 / 68 (2.94%)
         occurrences all number
    2
    2
    Tooth abscess
         subjects affected / exposed
    0 / 68 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 68 (5.88%)
    2 / 68 (2.94%)
         occurrences all number
    4
    2
    Urinary tract infection
         subjects affected / exposed
    2 / 68 (2.94%)
    2 / 68 (2.94%)
         occurrences all number
    2
    2
    Metabolism and nutrition disorders
    Hyperglycemia
         subjects affected / exposed
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences all number
    1
    4
    Hypoglycemia
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences all number
    2
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Oct 2013
    • Eligibility criteria were modified in order to define inadequately controlled SBP as an exclusion criterion. Consequently, Inclusion Criterion 7 was removed and a new Exclusion Criterion 9 was added. • Eligibility criteria were modified in order to exclude subjects with marked anemia. Consequently, Exclusion Criterion 18 was amended to specify that subjects with marked anemia defined as hemoglobin <10.0 g/dL (or 4.9 mmol/L) during screening were ineligible to enter the study. • Additional blood sampling points for PK and PD, and urinary PD were added. • Other changes were text clarifications and corrections with minimal impact on the study conduct or analysis.
    25 Mar 2014
    - Eligibility criteria were modified in order to allow the enrolment of subjects with stable thyroid disorder requiring hormone replacement therapy. Consequently, Exclusion Criterion 11 was amended to allow subject with stable doses of thyroid hormone(s) for at least 4 weeks prior to the first screening visit (Visit 1) and TSH values not greater than the upper limit of the normal range at Visit 1. - Eligibility criteria were modified in order to exclude subjects with a history of EPO use within the 4 weeks prior to Visit 1. Consequently Exclusion Criterion 21 was amended. • Other changes were text clarifications and corrections with minimal impact on the study conduct or analysis.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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