drugset / Trial / NCT01695759

Clinical Efficacy of Two Erythropoietin Drug in Participants With Secondary Anemia to Chronic Kidney Disease.

NCT01695759

Phase 3 Terminated 92 enrolled Azidus Brasil Blau Farmaceutica S.A. · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

This is a prospective, randomized, multicenter, parallel, placebo-controlled, phase III study for evaluation of clinical efficacy and immunogenicity of drug Eritromax® - (rHuEPO Blau Farmacêutica S/A.) compared to Eprex® (Janssen-Cilag rHuEPO) for the treatment of patients with secondary anemia to chronic kidney disease (CKD), throughout the correction phase by assessing the change in hemoglobin levels.

Timeline

Start
2013-12
Primary completion
2014-12
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Subject epoetin alfa Protein / enzyme biologic 50 iu/kg Subcutaneous