drugset / Trial / NCT02522975
Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study)
Phase 4
Terminated
16 enrolled
Shenyang Sunshine Pharmaceutical Co., LTD.
Navitas Life Sciences GmbH · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is aimed to comprehensively establish the biosimilarity/bioquivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy,safety and immunogenicity.The targeted population is anaemia patients with chronic renal disease who are naive to epoetin treatment and not yet on haemodialysis.
Timeline
- Start
- 2015-08
- Primary completion
- 2019-06
- Completion
- 2019-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | epoetin alfa | Protein / enzyme biologic | 60 iu/kg | Subcutaneous |