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Comparison of the Efficacy of Erythropoietin Produced in the Institute of Technology in Immunobiology of the Oswald Cruz Foundation (BioMaguinhos/FioCruz/MS) and Erythropoietin Industrialized in Patients With Chronic Renal Failure
A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis
Details
| Lead sponsor | Hospital de Clinicas de Porto Alegre |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 74 |
| Start date | 2008-04 |
| Completion | 2009-01 |
Conditions
- Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis
Interventions
- Epoetin Alfa-BioManguinhos
- Epoetin Alfa-BioSimilar
Primary outcomes
- Hemoglobin Level in blood — Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months
The evaluation of the efficacy between different formulations of recombinant EPO: the one produced by Bio-Manguinhos and produced by private industry was observed in response to EPO as measured by levels of hemoglobin (Hb) results. The mean Hb of the two groups were compared, as well as the variation observed in both groups over time follow-up (six months).