NCT02708914

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

December 6, 2023

Status Verified

May 1, 2022

Enrollment Period

5.6 years

First QC Date

February 23, 2016

Last Update Submit

November 29, 2023

Conditions

Renal Anemia

Outcome Measures

Primary Outcomes (4)

  • 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

  • Immunogenicity: occurrence of anti-erythropoietin antibody

    up to 52 weeks

Study Arms (2)

UB-851

OTHER
Biological: UB-851

Eprex then UB-851

OTHER
Biological: UB-851Biological: Eprex

Interventions

UB-851BIOLOGICAL

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

Eprex then UB-851UB-851
EprexBIOLOGICAL

Eprex® is chosen as the comparator.

Eprex then UB-851

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Epoetin Alfa

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 15, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

December 6, 2023

Record last verified: 2022-05