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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02708914

Enrollment

269

Registered

2016-03-15

Start date

2016-03-31

Completion date

2021-10-31

Last updated

2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Anemia

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.

Interventions

BIOLOGICALUB-851

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

BIOLOGICALEprex

Eprex® is chosen as the comparator.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

Inclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
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)
Adverse events (AEs): incidence and severity of all drug-related AEs	up to 52 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026