Back to resultsStudy to Compare the Safety and Efficacy of UB-851 and Eprex®
Primary Purpose
Renal Anemia
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
UB-851
Eprex
Sponsored by
About this trial
This is an interventional treatment trial for Renal Anemia
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
UB-851
Eprex then UB-851
Arm Description
Outcomes
Primary Outcome Measures
Mean change in hemoglobin (Hb) levels
Mean change in weekly epoetin dosage. between baseline and the evaluation period
Adverse events (AEs): incidence and severity of all drug-related AEs
Immunogenicity: occurrence of anti-erythropoietin antibody
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02708914
Brief Title
Study to Compare the Safety and Efficacy of UB-851 and Eprex®
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UBI Pharma Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UB-851
Arm Type
Other
Arm Title
Eprex then UB-851
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
UB-851
Intervention Description
UB-851 (rhEPO) has been developed as a biosimilar product to Eprex®.
Intervention Type
Biological
Intervention Name(s)
Eprex
Intervention Description
Eprex® is chosen as the comparator.
Primary Outcome Measure Information:
Title
Mean change in hemoglobin (Hb) levels
Time Frame
Baseline and the evaluation period (evaluation period: Week21-Week24)
Title
Mean change in weekly epoetin dosage. between baseline and the evaluation period
Time Frame
Baseline and the evaluation period (evaluation period: Week21-Week24)
Title
Adverse events (AEs): incidence and severity of all drug-related AEs
Time Frame
up to 52 weeks
Title
Immunogenicity: occurrence of anti-erythropoietin antibody
Time Frame
up to 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
12. IPD Sharing Statement
Learn more about this trial
Study to Compare the Safety and Efficacy of UB-851 and Eprex®
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