drugset / Trial / NCT06352138
Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis
Timeline
- Start
- 2025-07
- Primary completion
- 2027-03
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epoetin alfa Megalabs® | Protein / enzyme biologic | — | Intravenous |
| Comparator | epoetin alfa | Protein / enzyme biologic | — | Intravenous |