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

NCT02708914 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2023-12-06

No results posted yet for this study

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.

Conditions

  • Renal Anemia

Interventions

BIOLOGICAL

UB-851

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

BIOLOGICAL

Eprex

Eprex® is chosen as the comparator.

Sponsors & Collaborators

  • UBI Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2021-10-31
Completion
2021-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02708914 on ClinicalTrials.gov