Study to Compare the Safety and Efficacy of UB-851 and Eprex®

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure receiving hemodialysis.

Detailed Description
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This is a 52-week, phase III trial consisting of two parts: Part I is designed as a double-blind, randomized, multicenter, parallel-group study to evaluate the efficacy and safety of UB-851 in comparison to Eprex® in subjects with renal anemia on hemodialysis with a treatment period of 24 weeks. Part II is designed as a single-arm, safety evaluation period (from week 25 to week 52) to evaluate the long-term safety and immunogenicity of UB-851.

Official Title
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A Phase III Trial to Compare the Safety and Efficacy of Intravenous UB-851 and Eprex® With an Extension Safety Evaluation in Subjects With Renal Anemia on Hemodialysis

Conditions
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Renal Anemia

Intervention / Treatment
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* Biological: UB-851
* Biological: Eprex


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Subjects signed informed consent before undergoing any study procedures. Subjects aged 20 to 85 years. Hemodialysis subjects with chronic renal failure and renal anemia in outpatient clinic currently on stable Eprex® treatment administered by intravenous injection (1 to 3 times per week) for at least 3 months prior to randomization. Main Exclusion Criteria: Maintenance epoetin dose > 300 IU/kg per week. Treatment with long-acting epoetin analogues. Detectable anti-erythropoietin antibodies with clinical symptoms at screening visit, or history of Pure Red Cell Aplasia (PRCA).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: UB-851<br> | Biological: UB-851<br>* UB-851 (rhEPO) has been developed as a biosimilar product to Eprex®.<br>|
| Other: Eprex then UB-851<br> | Biological: UB-851<br>* UB-851 (rhEPO) has been developed as a biosimilar product to Eprex®.<br>Biological: Eprex<br>* Eprex® is chosen as the comparator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in hemoglobin (Hb) levels |  | Baseline and the evaluation period (evaluation period: Week21-Week24) | 
| Mean change in weekly epoetin dosage. between baseline and the evaluation period |  | Baseline and the evaluation period (evaluation period: Week21-Week24) | 
| Adverse events (AEs): incidence and severity of all drug-related AEs |  | up to 52 weeks | 
| Immunogenicity: occurrence of anti-erythropoietin antibody |  | up to 52 weeks |