Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Anemia |
Therapuetic Areas: | Hematology, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2013 |
End Date: | December 2015 |
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
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
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
Inclusion Criteria:
- - 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
- Exclusion Criteria:
- 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
We found this trial at
41
sites
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