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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Anemia, Chronic Kidney Disease (CKD)

Intervention / Treatment
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* Drug: HX575 epoetin alfa
* Drug: US-licensed epoetin alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HX575 epoetin alfa<br>HX575, recombinant human epoetin alfa | Drug: HX575 epoetin alfa<br>* 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.<br>* Other names: Abseamed® (Europe);|
| Active Comparator: US-licensed epoetin alfa<br>US-licensed recombinant human epoetin alfa | Drug: US-licensed epoetin alfa<br>* Solution for subcutaneous injection.<br>* Other names: Procrit®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (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 . | Week -4 to Day1 and Week 21-28 | 
| Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (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 . | Week -4 to Day1 and Week 21-28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Weekly Dose During Evaluation Period (Week 21-28) | Mean weekly study drug dose during evaluation period (Week 21-28) | Week 21-28 | 
| Incidence of Antibody Formation Against Epoetin | 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. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erythropoietin alfa, CKD 5d