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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Anemia
• Intervention / Treatment: Biological: UB-851; Biological: Eprex

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 Type: Interventional
• Enrollment (Actual): 269
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: UBI Pharma Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: February 23, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimated): March 15, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: P304-EPO