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

Renal Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708914
• Other study ID #: P304-EPO
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: October 2021

Study information

• Verified date: May 2022
• Source: UBI Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anemia
• Renal Anemia

Intervention

Biological:
• UB-851
UB-851 (rhEPO) has been developed as a biosimilar product to Eprex®.
• Eprex
Eprex® is chosen as the comparator.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UBI Pharma Inc.

Outcome

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