Anemia, Renal Insufficiency, Chronic
Conditions
Keywords
Anemia of CKD on dialysis
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.
Interventions
Subjects will continue with the same treatment they were receiving in the parent study (16208). BAY85-3934 will be administered daily as oral tablets. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits, the dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose. Total treatment time is up to 36 months. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.
BIOLOGICALEpoetin alfa/beta
Subjects will continue with the same treatment they were receiving in the parent study (16208). Epoetin alfa / beta will be administered as intravenous (IV) or subcutaneous (SC) injections per individual subject regimen according to the local label. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits,dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose.Total treatment time is up to 36 months.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Maintenance in hemoglobin target range (10.0 to 11.0 g/dL) | Up to 36 months |
| Maintenance in hemoglobin target range (9.5 to 11.5 g/dL) | Up to 36 months |
| Duration of treatment exposure | Up to 36 months |
| Number of subjects requiring titration of dose | Up to 36 months |
| Change of reticulocyte count from baseline of this study | Baseline up to 36 months |
| Change of reticulocyte count from baseline of study 16208 | Baseline up to 36 months |
| Change of red blood cell count from baseline of this study | Baseline up to 36 months |
| Change of red blood cell 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 |
| Change of central laboratory hemoglobin level 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 |
Countries
Japan, United States
Outcome results
None listed