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Completed

NCT Number: NCT02708914

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

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.

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Key information

Conditions

Renal Anemia

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

UB-851

Biological

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

Eprex

Biological

Eprex® is chosen as the comparator.

Primary outcomes

  1. Mean change in hemoglobin (Hb) levels

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

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

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

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

    Time frame: up to 52 weeks

  4. Immunogenicity: occurrence of anti-erythropoietin antibody

    Time frame: up to 52 weeks

Sponsors and collaborators

Lead sponsor

UBI Pharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2016
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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