check_circleStudy Completed

Anemia, Renal Insufficiency, Chronic

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 of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - - Eligible subjects will have a diagnosis of anemia associated with CKD(chronic kidney disease).
    - Women without childbearing potential
    - Male or female subject ≥ 18 years of age with anemia of CKD at screening
    - On dialysis, defined as regular long-term hemodialysis, with the same modality of dialysis for ≥ 3 months before randomization
    - Dialysis vascular access via native arteriovenous fistula, synthetic graft, long-term catheters, or long-term tunneled catheters
    -Treated with epoetin alfa (US or Japan) or epoetin beta (Japan) via intravenous (IV) or subcutaneous (SC) route, on stable dosing defined as a < 50% change from the maximum prescribed weekly dose with no change in the prescribed frequency during the last 8 weeks prior to randomization
    - At least one kidney
    - Mean screening Hb concentration 9.0 to 11.5 g/dL inclusive (mean of all local laboratory Hb measurements [at least 2 measurements must be taken ≥ 2 days apart] during the 4 week screening period, AND none of the measurements can be < 9.0 g/dL or > 12.0 g /dL
    - Serum ferritin levels ≥ 100 μg/L OR transferrin saturation ≥ 20% at screening. Iron substitution is allowed
    - Folate and vitamin B12 levels above the lower limit of normal. Supplementation is allowed

    -
  • - Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
    - Hereditary hemoglobinopathies (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia
    -Chronic lymphoproliferative diseases
    - Any allograft (including renal allograft) in place and on immunosuppressive therapy, or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)
    - Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease)
    - Subjects treated with immuno- or myelosuppressive therapy within 8 weeks prior to randomization: e.g., everolimus, sirolimus, rituximab, azathioprine, mycophenolate mofetil, mycophenolic acid, cyclosporine,methotrexate, and tacrolimus, chemotherapeutic agents and other anticancer agents, and systemic steroids (except inhaled steroids) for 7 days
    -RBC-containing transfusion within 8 weeks before randomization
    - History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from the initial screening visit
    - Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as a mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively
    - Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT >500 msec, second or third degree atrioventricular [AV]block if not treated with a pacemaker)
    - 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 times the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator’s opinion
    - A scheduled surgery that may be expected to lead to significant blood loss

Trial summary

Enrollment Goal
201
Trial Dates
October 2013 - December 2015
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
Completed
San Antonio, 78215, United States
Completed
Nashville, 37212-8150, United States
Completed
Los Angeles, 90025, United States
Withdrawn
Philadelphia, 19104, United States
Completed
Whittier, 90602, United States
Completed
Brooklyn, 11212, United States
Completed
Fresh Meadows, 11365, United States
Withdrawn
Baton Rouge, 70806, United States
Completed
Buffalo, 14215, United States
Completed
Detroit, 48202, United States
Completed
Eatontown, 07724, United States
Withdrawn
Tempe, 85284, United States
Completed
Toledo, 43615, United States
Completed
New Port Richey, 34652, United States
Withdrawn
Kalamazoo, 49007, United States
Completed
Nagano, 388-8004, Japan
Completed
Kyoto, 607-8116, Japan
Completed
Muroran, 050-0083, Japan
Withdrawn
Kanagawa, 210-0024, Japan
Completed
Himeji, 670-0947, Japan
Completed
Houston, 77091, United States
Withdrawn
Phoenix, 85027, United States
Withdrawn
Las Vegas, 89128, United States
Withdrawn
Glendale, 85301, United States
Withdrawn
Morgantown, 26505, 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
Completed
San Antonio, 78229, United States
Completed
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
Withdrawn
San Antonio, 78224, United States

Primary Outcome

  • Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
    date_rangeTime Frame:
    Baseline and weeks 14 to 17
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    Safety Issue:
    No

Secondary Outcome

  • Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)
    date_rangeTime Frame:
    From week 14 to 17
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    Safety Issue:
    No
  • Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)
    date_rangeTime Frame:
    From week 14 to 17
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    Safety Issue:
    No
  • Change from baseline in Hb during active treatment
    date_rangeTime Frame:
    Baseline and weeks 14 to 17
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    Safety Issue:
    No
  • Number of patients with hemoglobin levels outside the target range
    date_rangeTime Frame:
    From week 14 to 17
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    Safety Issue:
    No
  • Dose level in the evaluation period
    date_rangeTime Frame:
    Up to 16 weeks
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    Safety Issue:
    No
  • Duration of exposure on each dose level
    date_rangeTime Frame:
    Up to 16 weeks
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    Safety Issue:
    No
  • Number of subjects requiring titration of dose
    date_rangeTime Frame:
    Up to 16 weeks
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    Safety Issue:
    No
  • Number of participants with serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

A randomized, parallel group, open-label, multicenter study to investigate the efficacy and safety of oral BAY85-3934 and active comparator (epoetin alfa / beta) in the maintenance treatment of subjects with anemia associated with chronic kidney disease who are on dialysis and on treatment with an erythropoiesis-stimulating agent 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
5