drugset / Trial / NCT06352138

Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients

NCT06352138

Phase 3 Not yet recruiting 280 enrolled Megalabs
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

EvaluationDrugModalityDoseRoute
Subject Epoetin alfa Megalabs® Protein / enzyme biologic Intravenous
Comparator epoetin alfa Protein / enzyme biologic Intravenous