drugset / Trial / NCT02064426
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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-03-13
- Primary completion
- 2016-10-19
- Completion
- 2016-11-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Molidustat | Small molecule | 15 mg | Oral |
| Subject | Molidustat | Small molecule | 25 mg | Oral |
| Subject | Molidustat | Small molecule | 50 mg | Oral |
| Subject | Molidustat | Small molecule | 75 mg | Oral |
| Subject | Molidustat | Small molecule | 100 mg | Oral |
| Subject | Molidustat | Small molecule | 150 mg | Oral |
| Comparator | epoetin alfa | Protein / enzyme biologic | — | Intravenous |