check_circleStudy Completed

Anemia, Renal Insufficiency, Chronic

Bayer Identifier:

16209

ClinicalTrials.gov Identifier:

NCT02064426

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
88
Trial Dates
March 2014 - November 2016
Phase
Phase 2
Could I Receive a placebo
No
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Cincinnati, 45206, United States
Completed
San Dimas, 91773, United States
Completed
Azusa, 91702, United States
Withdrawn
San Antonio, 78215, United States
Completed
Nashville, 37212-8150, United States
Withdrawn
Los Angeles, 90025, United States
Withdrawn
Philadelphia, 19104, United States
Completed
Whittier, 90602, United States
Withdrawn
Brooklyn, 11212, United States
Withdrawn
Fresh Meadows, 11365, United States
Completed
Buffalo, 14215, United States
Completed
Detroit, 48202, United States
Withdrawn
Eatontown, 07724, United States
Withdrawn
Tempe, 85284, United States
Completed
Toledo, 43615, United States
Completed
New Port Richey, 34652, United States
Withdrawn
Nagano, 388-8004, Japan
Completed
Kyoto, 607-8116, Japan
Completed
Muroran, 050-0083, Japan
Withdrawn
Kanagawa, 210-0024, Japan
Withdrawn
Himeji, 670-0947, Japan
Completed
Houston, 77091, United States
Completed
Mansfield, 76063, United States
Completed
Fort Worth, 76105, United States
Completed
Fort Worth, 76104, United States
Completed
Fort Worth, 76164, United States
Completed
Northridge, 91324, United States
Completed
Kuwana, 511-0061, Japan
Completed
Oklahoma City, 73116, United States
Withdrawn
San Antonio, 78229, United States
Withdrawn
Detroit, 48236, United States
Completed
Pembroke Pines, 33028, United States
Completed
Creve Coeur, 63141, United States
Completed
Long Beach, 90813, United States
Completed
Houston, 77004, United States
Completed
Lynwood, 90262, United States
Completed
Whittier, 90606, United States
Completed
Grand Prairie, 75050, United States
Withdrawn
San Antonio, 78207, United States

Primary Outcome

  • Change in local laboratory hemoglobin level from baseline
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Maintenance in hemoglobin target range (10.0 to 11.0 g/dL)
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Maintenance in hemoglobin target range (9.5 to 11.5 g/dL)
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Duration of treatment exposure
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects requiring titration of dose
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of reticulocyte count from baseline of this study
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of reticulocyte count from baseline of study 16208
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of red blood cell count from baseline of this study
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of red blood cell count from baseline of study 16208
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of hematocrit from baseline of this study
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of hematocrit from baseline of study 16208
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of central laboratory hemoglobin level from baseline of this study
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of central laboratory hemoglobin level from baseline of study 16208
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

A controlled, parallel group, open-label, multicenter extension study to investigate efficacy and safety of oral BAY85-3934 and active comparator (epoetin alfa / beta) in the long-term treatment of subjects with anemia associated with chronic kidney disease who are on dialysis in the United States and Japan
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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