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NCT04877288 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications
A Phase 3 study of Renal Allograft Recipients, sponsored by Bristol-Myers Squibb.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
- 20
- Study locations
NCT04877288 is a Phase 3 study of Renal Allograft Recipients that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 102 participants. The trial reports 20 study locations across 16 states.
The verdict
NCT04877288, a Phase 3 study of Renal Allograft Recipients, is actively recruiting participants, sponsored by Bristol-Myers Squibb.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.
Conditions Studied
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Tacrolimus
- DRUG Cyclosporine A
- BIOLOGICAL Belatacept
- DRUG Enteric Coated Mycophenolate Sodium
Study Locations (20)
Other
- Local Institution - 0062 - Buenos Aires
- UZ Gent-Paediatric Nephrology and Rheumatology Department - Ghent
- Bordeaux University Hospital - Pellegrin-Pediatrics - Bordeaux
Florida
- Local Institution - 0022 - Hollywood
- Local Institution - 0045 - Miami
Ohio
- Local Institution - 0025 - Cincinnati
- Local Institution - 0048 - Cleveland
Alabama
- Local Institution - 0042 - Birmingham
California
- Local Institution - 0041 - Los Angeles
District of Columbia
- Local Institution - 0014 - Washington D.C.
Georgia
- Local Institution - 0049 - Atlanta
Illinois
- Local Institution - 0033 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2021-07-21 |
| Est. Completion | 2034-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04877288
The ClinicalTrials.gov registry entry for NCT04877288 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Renal Allograft Recipients appearing as the primary indexed condition, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT04877288 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT04877288 about?
NCT04877288 is a clinical study titled "A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications". The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adheren...
What is the current status of trial NCT04877288?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2021-07-21. Estimated completion is 2034-06-30.
What conditions does trial NCT04877288 study?
This clinical trial studies the following conditions: Renal Allograft Recipients.
What interventions are being tested in trial NCT04877288?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Tacrolimus (DRUG), Cyclosporine A (DRUG), Belatacept (BIOLOGICAL), Enteric Coated Mycophenolate Sodium (DRUG).
Who is sponsoring clinical trial NCT04877288?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04877288 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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