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

Phase 3

Completed

• Conditions: Renal Anemia
• Interventions: Biological: UB-851; Biological: Eprex

• Registration Number: NCT02708914
• Lead Sponsor: UBI Pharma Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-02-23
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-15
• Primary Completion: 2021-10
• Study Completion: 2021-10
• Status Verified: 2022-05
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UB-851	UB-851	-
Eprex then UB-851	UB-851	-
Eprex then UB-851	Eprex	-

Primary Outcome Measures

Name	Time	Method
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
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)