drugset / Trial / NCT03519243
Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis
RandomizedParallel-groupOpen-labelTreatment
Summary
BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis.
Timeline
- Start
- 2017-10-24
- Primary completion
- 2018-12-01
- Completion
- 2018-12-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCD-131 | Protein / enzyme biologic | 1.05 ug/kg | Subcutaneous |
| Subject | BCD-131 | Protein / enzyme biologic | 1.7 ug/kg | Subcutaneous |
| Subject | BCD-131 | Protein / enzyme biologic | 2.75 ug/kg | Subcutaneous |
| Comparator | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | — | Subcutaneous |