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

UBI Pharma Inc.269 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

269

Conditions

Renal Anemia

Interventions

UB-851BIOLOGICAL

UB-851 (rhEPO) has been developed as a biosimilar product to Eprex®.

EprexBIOLOGICAL

Eprex® is chosen as the comparator.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Main Inclusion Criteria: 1. Subjects signed informed consent before undergoing any study procedures. 2. Subjects aged 20 to 85 years. 3. 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: 1. Maintenance epoetin dose \> 300 IU/kg per week. 2. Treatment with long-acting epoetin analogues. 3. Detectable anti-erythropoietin antibodies with clinical symptoms at screening visit, or history of Pure Red Cell Aplasia (PRCA).

Outcomes

Primary Outcomes

Mean change in hemoglobin (Hb) levels

Time frame: Baseline and the evaluation period (evaluation period: Week21-Week24)

Mean change in weekly epoetin dosage. between baseline and the evaluation period

Time frame: Baseline and the evaluation period (evaluation period: Week21-Week24)

Adverse events (AEs): incidence and severity of all drug-related AEs

Time frame: up to 52 weeks

Immunogenicity: occurrence of anti-erythropoietin antibody

Time frame: up to 52 weeks

Data from ClinicalTrials.gov

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