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

NCT ID: NCT02708914

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2021-10-31

Brief Summary

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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

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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.

Conditions

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Renal Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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UB-851

Group Type OTHER

UB-851

Intervention Type BIOLOGICAL

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

Eprex then UB-851

Group Type OTHER

UB-851

Intervention Type BIOLOGICAL

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

Eprex

Intervention Type BIOLOGICAL

Eprex® is chosen as the comparator.

Interventions

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UB-851

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

Intervention Type BIOLOGICAL

Eprex

Eprex® is chosen as the comparator.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UBI Pharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P304-EPO

Identifier Type: -

Identifier Source: org_study_id