drugset / Trial / NCT04155125
A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
Phase 3
Completed
391 enrolled
PT Kalbe Genexine Biologics
Novotech (Australia) Pty Limited · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects who have CKD and are not on dialysis. ESA prior users who have stopped using ESA at least 12 weeks till screening will also be eligible for this study provided they fulfil all the subject entry criteria.
Timeline
- Start
- 2020-07-02
- Primary completion
- 2022-03-30
- Completion
- 2023-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efepoetin Alfa | Protein / enzyme biologic | 4 ug/kg | Subcutaneous |
| Comparator | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 0.6 ug/kg | Subcutaneous |