drugset / Trial / NCT04036253

Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease

NCT04036253

Phase 3 Completed 43 enrolled Bio Sidus SA
RandomizedParallel-groupSingle-blindTreatment

Summary

Phase III, multicenter, randomized, open, controlled clinical trial. A study designed as phase III, in 120 patients with chronic renal failure in the pre-dialysis stage, evaluate efficacy and safety of Hemax PFS® (PFS: prefilled syringes) vs the innovator erythropoietin alfa product (Eprex®).

Timeline

Start
2018-02-28
Primary completion
2021-06-15
Completion
2021-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject epoetin alfa Protein / enzyme biologic 29 iu/kg Subcutaneous