drugset / Trial / NCT01695759
Clinical Efficacy of Two Erythropoietin Drug in Participants With Secondary Anemia to Chronic Kidney Disease.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 50 iu/kg | Subcutaneous |