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

Recruiting now · Phase 3

Conditions studied: Renal Allograft Recipients

In brief

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.

Key facts

Study ID: NCT04877288
Run by: Bristol-Myers Squibb
People needed: 102
Starts: 2021-07-21
Expected to finish: 2034-06-30
Last updated by the study team: 2026-06-25

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team — Nottingham, United Kingdom (enrolling)
Hospital Italiano de Buenos Aires — ABB, Buenos Aires F.D., Argentina (enrolling)
UZ Gent-Paediatric Nephrology and Rheumatology Department — Ghent, Belgium (enrolling)
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes, Loire-Atlantique, France (enrolling)
Bordeaux University Hospital - Pellegrin-Pediatrics — Bordeaux, France (enrolling)
Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique — Bron, France (enrolling)
Hopital De La Timone — Marseille, France (enrolling)
Hopital Necker — Paris, France (enrolling)
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita — Paris, France (enrolling)
Universitaetsklinikum Essen — Essen, North Rhine-Westphalia, Germany (enrolling)
Universitaetsklinikum Koeln-Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung für Pädia — Cologne, Germany (enrolling)
Local Institution - 0026 — Heidelberg, Germany (enrolling)
IRCCS Istituto Giannina Gaslini — Genoa, Liguria, Italy (enrolling)
Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale — Torino, Italy (enrolling)
Emma Children (AMC) — Amsterdam, Netherlands (enrolling)
Local Institution - 0061 — Oslo, Norway
Local Institution - 0062 — Buenos Aires, Argentina
Local Institution - 0001 — Barcelona, Spain
Local Institution - 0011 — Hamburg, Germany
Local Institution - 0012 — Rivas-Vaciamadrid, Spain
Local Institution - 0003 — Seville, Spain
Local Institution - 0030 — Milan, Italy
Local Institution - 0008 — Manchester, United Kingdom
Local Institution - 0042 — Birmingham, Alabama, United States
Local Institution - 0041 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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