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
NCT ID: NCT04877288
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
102 participants
INTERVENTIONAL
2021-07-21
2034-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap
Conversion followed by tapering and discontinuation of the calcineurin inhibitor (CNI)
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
Arm 2: Continue calcineurin inhibitor-based regimen
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Local Institution - 0060
ABB, Buenos Aires F.D., Argentina
Local Institution - 0062
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
Local Institution - 0010
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
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Site 0060
Role: primary
Site 0062
Role: primary
Agnieszka Prytula, Site 0047
Role: primary
Gwenaelle Roussey, Site 0055
Role: primary
Jerome Harambat, Site 0056
Role: primary
Anne-Laure SELLIER-LECLERC, Site 0028
Role: primary
Florentine Garaix, Site 0054
Role: primary
Olivia Boyer, Site 0027
Role: primary
Julien Hogan, Site 0029
Role: primary
Lars Pape, Site 0057
Role: primary
Site 0010
Role: primary
Site 0011
Role: primary
Site 0026
Role: primary
ENRICO VERRINA, Site 0059
Role: primary
Site 0030
Role: primary
Licia Peruzzi, Site 0036
Role: primary
Antonia Bouts, Site 0015
Role: primary
Site 0061
Role: primary
Jon Jin Kim, Site 0009
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2022-501677-39
Identifier Type: OTHER
Identifier Source: secondary_id
IM103-402
Identifier Type: -
Identifier Source: org_study_id