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COMPLETEDPhase 3NCT01693029

Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa

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 su...

Lead sponsor: Sandoz•52 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Sandoz

This is a 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 (CKD).

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous maintenance therapy with Epogen® or Procrit® at least once per week
•Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period
•Adequate iron substitution

Exclusion Criteria

•Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy
•History of Pure Red Cell Aplasia (PRCA), or anti-erythropoietin (EPO) antibodies
•Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection
•Hepatitis C infection on an active treatment
•Symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III and IV)
•Unstable angina pectoris, or cardiac infarction during the last 6 months prior to randomization
•Percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to randomization
•History of malignancy of any organ system
•Systemic lupus erythematous
•Immunocompromized patients

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 2, 2017Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment435

Start dateSep 2012

Last updatedJul 2, 2017

Condition

Anemia Chronic Kidney Disease (CKD)

Locations shown

Southwestern Kidney Institute

Tempe, Arizona

North America Research Institute

Azusa, California

Pegasus Dialysis, LLC

Bakersfield, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2017Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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