Renal AnemiaPhase 3NCT02708914
Study to Compare the Safety and Efficacy of UB-851 and Eprex®
A Phase 3 study testing UB-851 and Eprex in people with Renal Anemia, run by UBI Pharma Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Renal Anemia
- What is being tested?
- UB-851 and Eprex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
About this study
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
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.
Read the 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.
- Conditions
- Renal Anemia
- Being tested
- UB-851, Eprex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-851Biological
UB-851 (rhEPO) has been developed as a biosimilar product to Eprex®.
EprexBiological
Eprex® is chosen as the comparator.
| Study group | Role | What they receive |
|---|---|---|
| UB-851 | Other | Not described Receives: Biological: UB-851 |
| Eprex then UB-851 | Other | Not described Receives: Biological: UB-851; Biological: Eprex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in hemoglobin (Hb) levels
Measured: Baseline and the evaluation period (evaluation period: Week21-Week24)
Mean change in weekly epoetin dosage. between baseline and the evaluation period
Measured: Baseline and the evaluation period (evaluation period: Week21-Week24)
Adverse events (AEs): incidence and severity of all drug-related AEs
Measured: up to 52 weeks
Immunogenicity: occurrence of anti-erythropoietin antibody
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- UBI Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708914
- Sponsor's protocol ID
- P304-EPO
- Status last verified
- May 2022
- First submitted
- 23 Feb 2016
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02708914
- Acronym / sponsor ID
- P304-EPO
- Conditions
- Renal Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- UBI Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UB-851 | Other | Biological: UB-851 |
| Eprex then UB-851 | Other | Biological: UB-851, Biological: Eprex |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UB-851UB-851 (rhEPO) has been developed as a biosimilar product to Eprex®. | Biological | Eprex then UB-851, UB-851 |
| EprexEprex® is chosen as the comparator. | Biological | Eprex then UB-851 |
Primary outcome
Mean change in hemoglobin (Hb) levels
Time frame: Baseline and the evaluation period (evaluation period: Week21-Week24)
Mean change in weekly epoetin dosage. between baseline and the evaluation period
Time frame: Baseline and the evaluation period (evaluation period: Week21-Week24)
Adverse events (AEs): incidence and severity of all drug-related AEs
Time frame: up to 52 weeks
Immunogenicity: occurrence of anti-erythropoietin antibody
Time frame: up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UB-851 and Eprex in people with Renal Anemia, run by UBI Pharma Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in hemoglobin (Hb) levels (time frame: Baseline and the evaluation period (evaluation period: Week21-Week24)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.