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

Completed · Phase 3

Conditions studied: Anemia, Chronic Kidney Disease (CKD)

In brief

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.

Key facts

Study ID

NCT01693029

Run by

Sandoz

People needed

435

Starts

2012-09-01

Expected to finish

2015-03-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Other In-/Exclusion criteria may apply

Where it is running

• North America Research Institute — Azusa, California, United States
• Pegasus Dialysis, LLC — Bakersfield, California, United States
• Central Nephrology Medical Group — Bakersfield, California, United States
• California Institute of Renal Research — Chula Vista, California, United States
• Renal Consultants Medical Group — Granada Hills, California, United States
• Angel Kidney Care of Inglewood Dialysis Center — Inglewood, California, United States
• California Institute of Renal Research — La Mesa, California, United States
• Alliance Research Centers — Laguna Hills, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center — Los Angeles, California, United States
• Tower Nephrology Medical Group — Los Angeles, California, United States
• St Vincent Dialysis Center — Los Angeles, California, United States
• Kidney Research Center — Lynwood, California, United States
• Valley Renal Medical Group — Northridge, California, United States
• Ontario Dialysis, Inc. — Ontario, California, United States
• Apex Research of Riverside — Riverside, California, United States
• Capital Nephrology Medical Group — Sacramento, California, United States
• California Institute of Renal Research — San Diego, California, United States
• La Jolla Clinical Research, Inc. — San Diego, California, United States
• North America Research Institute — San Dimas, California, United States
• American Institute of Research — Whittier, California, United States
• South Florida Nephrology — Coral Springs, Florida, United States
• Pines Clinical Research Inc. — Hollywood, Florida, United States
• Genesis Clinical Research Corporation — Tampa, Florida, United States
• Southwestern Kidney Institute — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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