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

Phase 3

Completed

Brief 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.

Detailed Description: 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).

Recruitment & Eligibility

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

Other In-/Exclusion criteria may apply

Arm && Interventions

Group	Intervention	Description
HX575 epoetin alfa	HX575 epoetin alfa	HX575, recombinant human epoetin alfa
US-licensed epoetin alfa	US-licensed epoetin alfa	US-licensed recombinant human epoetin alfa

Primary Outcome Measures

Name	Time	Method
Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)	Week -4 to Day1 and Week 21-28	Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)	Week -4 to Day1 and Week 21-28	Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .

Secondary Outcome Measures

Name	Time	Method
Mean Weekly Dose During Evaluation Period (Week 21-28)	Week 21-28	Mean weekly study drug dose during evaluation period (Week 21-28)
Incidence of Antibody Formation Against Epoetin	52 weeks	Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.

Locations (49): Southwestern Kidney Institute
🇺🇸
Tempe, Arizona, United States
North America Research Institute
🇺🇸
San Dimas, California, United States
Pegasus Dialysis, LLC
🇺🇸
Bakersfield, California, United States
Central Nephrology Medical Group
🇺🇸
Bakersfield, California, United States
California Institute of Renal Research
🇺🇸
San Diego, California, United States
Renal Consultants Medical Group
🇺🇸
Granada Hills, California, United States
Angel Kidney Care of Inglewood Dialysis Center
🇺🇸
Inglewood, 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
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Southwestern Kidney Institute
🇺🇸Tempe, Arizona, United States