RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Bristol-Myers Squibb • ClinicalTrials.gov ID: NCT04877288

Registry updated: 2026-08-31

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Description

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.

Interventions

Belatacept (Biological)
Specified dose on specified days
Tacrolimus (Drug)
Specified dose on specified days
Cyclosporine A (Drug)
Specified dose on specified days
Mycophenolate Mofetil (Drug)
Specified dose on specified days
Enteric Coated Mycophenolate Sodium (Drug)
Specified dose on specified days
Corticosteroids (Drug)
Specified dose on Specified days

Eligibility criteria

Inclusion Criteria: * Male and female adolescents 12 to less than 18 years of age * Recipients of a renal allograft from a living or deceased donor transplanted at least 6 calendar months prior to enrollment * Receiving a stable regimen of a calcineurin inhibitor (CNI), with mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium/mycophenolate mofetil (EC-MPS/MPA), with or without daily corticosteroids for ≥ 30 days prior to randomization * Clinically stable renal function during the 12-week period prior to screening, in the opinion of the investigator and based on protocol-defined criteria for proteinuria and estimated glomerular filtration rate (eGFR) * Serologic evidence of past exposure to Epstein-Barr virus (EBV) and current absence of EBV DNA replication at or prior to renal transplantation and during the Screening period * Completion of an initial course of SARS-CoV-2 vaccination per local standard of care, a minimum of 6 weeks prior to enrollment Exclusion Criteria: * Recipients with EBV serostatus negative or unknown at screening or at transplant * Treatment for biopsy-proven acute rejection (BPAR) of any degree of severity within 6 calendar months prior to enrollment * Biopsy-confirmed antibody-mediated acute rejection at any time with the current allograft * Banff 97 grade IIA or higher acute cellular rejection (or equivalent), or treatment with plasmapheresis or rituximab for any acute rejection at any time with the current allograft * Current evidence or past history of active or inadequately treated latent tuberculosis (TB) infection * Previously treated with belatacept or previously enrolled in a belatacept trial with their present allograft Other inclusion/exclusion criteria apply

Conditions

Renal Allograft Recipients

Locations

Local Institution - 0042 — Birmingham, Alabama, United States
Local Institution - 0041 — Los Angeles, California, United States
Local Institution - 0014 — Washington D.C., District of Columbia, United States
Local Institution - 0022 — Hollywood, Florida, United States
Local Institution - 0045 — Miami, Florida, United States
Local Institution - 0049 — Atlanta, Georgia, United States
Local Institution - 0033 — Chicago, Illinois, United States
Local Institution - 0017 — Baltimore, Maryland, United States
Local Institution - 0044 — Boston, Massachusetts, United States
Local Institution - 0043 — St Louis, Missouri, United States
Local Institution - 0024 — Durham, North Carolina, United States
Local Institution - 0025 — Cincinnati, Ohio, United States
Local Institution - 0048 — Cleveland, Ohio, United States
Local Institution - 0052 — Portland, Oregon, United States
Local Institution - 0038 — Seattle, Washington, United States
Hospital Italiano de Buenos Aires — ABB, Buenos Aires F.D., Argentina
Instituto de Trasplantes y Alta Complejidad — Buenos Aires, Argentina
UZ Gent-Paediatric Nephrology and Rheumatology Department — Ghent, Belgium
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes, Loire-Atlantique, France
Bordeaux University Hospital - Pellegrin-Pediatrics — Bordeaux, France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique — Bron, France
Hopital De La Timone — Marseille, France
Hopital Necker — Paris, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita — Paris, France
Universitaetsklinikum Essen — Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Koeln-Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung für Pädia — Cologne, Germany
Local Institution - 0011 — Hamburg, Germany
Local Institution - 0026 — Heidelberg, Germany
IRCCS Istituto Giannina Gaslini — Genoa, Liguria, Italy
Local Institution - 0030 — Milan, Italy
Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale — Torino, Italy
Emma Children (AMC) — Amsterdam, Netherlands
Local Institution - 0061 — Oslo, Norway
Local Institution - 0001 — Barcelona, Spain
Local Institution - 0012 — Rivas-Vaciamadrid, Spain
Local Institution - 0003 — Seville, Spain
Local Institution - 0008 — Manchester, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team — Nottingham, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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