CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 435 enrolled
Drug / intervention
HX575 epoetin alfa +1 moredrug
Likely dose
HX575 epoetin alfa 11 gfrom 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/NCT01693029
NCT01693029Phase 3Completed
CompareCT.gov

Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease

Sandoz·interventional·Posted Sep 26, 2012·Updated Jul 2, 2017

In Brief

A Phase 3 clinical trial evaluating HX575 epoetin alfa and US-licensed epoetin alfa for Anemia and Chronic Kidney Disease (CKD). Completed, enrolled 435 participants across 52 sites.

Detailed Summary

The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Chronic Kidney Disease (CKD)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 26, 2012
Enrollment StartSep 1, 2012
Primary CompletionMay 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.8 years ago

Interventions

HX575 epoetin alfadrug

Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.

US-licensed epoetin alfadrug

Solution for subcutaneous injection.