Efficacy Study of Two Formulations of Erythropoietin

Phase 3 Completed 74 enrolled Hospital de Clinicas de Porto Alegre Oswaldo Cruz Foundation · collab Rio Grande do Sul State Health Department - SES/RS · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis

Timeline

Start: 2008-04
Primary completion: 2008-12
Completion: 2009-01

Outcome

Met primary endpoint

paper The epoetin formulations tested in this study are equivalent in efficacy and safety. PMID 25141114 ↗

Publications

Picon PD, Pribbernow SC, Prompt CA, Schacher SC, Antunes VV, Mentz BP, Oliveira FL, Souza CM, Schacher FC. Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis. Clinics (Sao Paulo). 2014 Aug;69(8):547-53. doi: 10.6061/clinics/2014(08)08.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Epoetin Alfa-BioManguinhos	Unknown	—	Subcutaneous
Comparator	Epoetin Alfa-BioSimilar	Protein / enzyme biologic	—	Subcutaneous

Indications

No indication recorded.