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Clinical Trials in the UK / NCT04877288
Recruiting 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

NCT04877288 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2021-07-21
Last updated
2026-08-31

Condition(s) studied

Renal Allograft Recipients

Investigational drug(s) / intervention(s)

BelataceptTacrolimusCyclosporine AMycophenolate MofetilEnteric Coated Mycophenolate SodiumCorticosteroids

Belatacept: Specified dose on specified days

Tacrolimus: Specified dose on specified days

Cyclosporine A: Specified dose on specified days

Mycophenolate Mofetil: Specified dose on specified days

Enteric Coated Mycophenolate Sodium: Specified dose on specified days

Corticosteroids: Specified dose on Specified days

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (38)

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Local Institution - 0042 Birmingham Alabama Withdrawn
Local Institution - 0041 Los Angeles California Withdrawn
Local Institution - 0014 Washington D.C. District of Columbia Withdrawn
Local Institution - 0022 Hollywood Florida Withdrawn
Local Institution - 0045 Miami Florida Withdrawn
Local Institution - 0049 Atlanta Georgia Withdrawn
Local Institution - 0033 Chicago Illinois Withdrawn
Local Institution - 0017 Baltimore Maryland Withdrawn
Local Institution - 0044 Boston Massachusetts Withdrawn
Local Institution - 0043 St Louis Missouri Withdrawn
Local Institution - 0024 Durham North Carolina Withdrawn
Local Institution - 0025 Cincinnati Ohio Withdrawn
Local Institution - 0048 Cleveland Ohio Withdrawn
Local Institution - 0052 Portland Oregon Withdrawn
Local Institution - 0038 Seattle Washington Withdrawn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

More Bristol-Myers Squibb trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04877288 on ClinicalTrials.gov ↗ ← All trials in the UK