Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934

Phase 2

Completed

• Conditions: Renal Insufficiency, Chronic; Anemia
• Interventions: Biological: Epoetin alfa/beta; Drug: Molidustat (BAY85-3934)

• Registration Number: NCT02064426
• Lead Sponsor: Bayer

Brief Summary

Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once daily.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-03-13
• Primary Completion: 2016-10-19
• Study Completion: 2016-11-16
• Disposition First Submitted: 2017-02-27
• Disposition First Submitted QC: 2017-02-27
• Disposition First Posted: 2017-03-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Eligible male or female subjects were previously enrolled in Study 16208, have a diagnosis of anemia associated with CKD, and are on hemodialysis.
• Men who agree to use adequate contraception when sexually active or women without childbearing potential
• Participation and completion of treatment in Study 16208; subjects must have received 16 weeks of study medication and completed the end of treatment visit (Day 113) in the parent study
• Mean Hb concentration of 9.5 to 11.5 g/dL, inclusive, during the evaluation period (i.e., the last 4 weeks of the parent study) when the subject completed 16 weeks of treatment with BAY85-3934, epoetin alfa, or epoetin beta in Study 16208

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Exclusion Criteria

• A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
• Updates to medical and surgical history which meet the exclusion criteria in the parent study
• Subjects treated with immunosuppressive therapy and the breast cancer resistant protein (BCRP) substrates, irinotecan, topotecan, methotrexate, imatinib, and lapatinib
• Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively
• Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial fibrillation or flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block)
• New York Heart Association Class III or IV congestive heart failure
• Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST], or gamma-glutamyl transferase > 3 x the upper limit of norma [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator's opinion
• An ongoing SAE from Study 16208 that is assessed as related to study drug
• Alcohol or drug abuse

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epoetin alfa/beta	Epoetin alfa/beta	-
Molidustat (BAY85-3934)	Molidustat (BAY85-3934)	-

Primary Outcome Measures

Name	Time	Method
Change in local laboratory hemoglobin level from baseline	Baseline up to 36 months
Number of participants with serious adverse events as a measure of safety and tolerability	Up to 36 months

Secondary Outcome Measures

Name	Time	Method
Change of red blood cell count from baseline of study 16208	Baseline up to 36 months
Change of reticulocyte count from baseline of study 16208	Baseline up to 36 months
Change of hematocrit from baseline of this study	Baseline up to 36 months
Change of hematocrit from baseline of study 16208	Baseline up to 36 months
Maintenance in hemoglobin target range (9.5 to 11.5 g/dL)	Up to 36 months
Number of subjects requiring titration of dose	Up to 36 months
Change of red blood cell count from baseline of this study	Baseline up to 36 months
Duration of treatment exposure	Up to 36 months
Change of reticulocyte count from baseline of this study	Baseline up to 36 months
Change of central laboratory hemoglobin level from baseline of study 16208	Baseline up to 36 months
Maintenance in hemoglobin target range (10.0 to 11.0 g/dL)	Up to 36 months
Change of central laboratory hemoglobin level from baseline of this study	Baseline up to 36 months