drugset / Trial / NCT07119372
Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
RandomizedParallel-groupOpen-labelTreatment
Summary
BCD-131 is pegylated darbepoetin beta. This clinical study BCD-131-3 is a randomized, open-label, phase III study of the efficacy and safety of BCD-131 and Mircera used for the treatment of anemia in end-stage chronic kidney disease (CKD) patients on dialysis.
Timeline
- Start
- 2025-03-01
- Primary completion
- 2026-05
- Completion
- 2026-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCD-131 | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | — | Subcutaneous |