drugset / Trial / NCT00666835

Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients

NCT00666835

Phase 3 Completed 478 enrolled Sandoz Hexal AG · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose of ERYPO® intravenously.

Timeline

Start
2004-04
Primary completion
2006-01
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject epoetin alfa Protein / enzyme biologic 300 iu/kg Intravenous
Subject epoetin alfa Protein / enzyme biologic 1000 iu Intravenous
Subject epoetin alfa Protein / enzyme biologic 2000 iu Intravenous
Subject epoetin alfa Protein / enzyme biologic 4000 iu Intravenous

Indications