CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 478 enrolled
Drug / intervention
HX575 epoetin alfa Hexal AG +1 moredrug
Likely dose
HX575 epoetin alfa Hexal AG 4000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00666835
NCT00666835Phase 3Completed
CompareCT.gov

Randomized, Double-blind, Multicenter, Parallel-group, Equivalence Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients

Sandoz·interventional·Posted Apr 25, 2008·Updated Jul 3, 2023

In Brief

A Phase 3 clinical trial evaluating HX575 epoetin alfa Hexal AG and ERYPO®, Janssen-Cilag for Anemia. Completed, enrolled 478 participants across 54 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesAustria, Germany
CollaboratorsHexal AG

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 25, 2008
Enrollment StartApr 1, 2004
Primary CompletionJan 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.2 years ago

Interventions

HX575 epoetin alfa Hexal AGdrug

HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin

ERYPO®, Janssen-Cilagdrug

Solution for i.v. injection