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

Last updated: April 4, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Belatacept

Enteric Coated Mycophenolate Sodium

Mycophenolate Mofetil

Clinical Study ID

NCT04877288
IM103-402
2018-000237-12
  • Ages 12-17
  • All Genders

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 Criteria

Inclusion

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 atleast 6 calendar months prior to enrollment

  • Receiving a stable regimen of a calcineurin inhibitor (CNI), with mycophenolatemofetil (MMF) or enteric-coated mycophenolate sodium/mycophenolate mofetil (EC-MPS/MPA), with or without daily corticosteroids for ≥ 30 days prior torandomization

  • Clinically stable renal function during the 12-week period prior to screening, inthe opinion of the investigator and based on protocol-defined criteria forproteinuria and estimated glomerular filtration rate (eGFR)

  • Serologic evidence of past exposure to Epstein-Barr virus (EBV) and current absenceof EBV DNA replication at or prior to renal transplantation and during the Screeningperiod

  • Completion of an initial course of SARS-CoV-2 vaccination per local standard ofcare, a minimum of 6 weeks prior to enrollment

Exclusion

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 currentallograft

  • Banff 97 grade IIA or higher acute cellular rejection (or equivalent), or treatmentwith plasmapheresis or rituximab for any acute rejection at any time with thecurrent allograft

  • Current evidence or past history of active or inadequately treated latenttuberculosis (TB) infection

  • Previously treated with belatacept or previously enrolled in a belatacept trial withtheir present allograft

Other inclusion/exclusion criteria apply

Study Design

Total Participants: 102
Treatment Group(s): 6
Primary Treatment: Belatacept
Phase: 3
Study Start date:
July 21, 2021
Estimated Completion Date:
December 30, 2031

Connect with a study center

  • Local Institution - 0060

    ABB, Ciudad Autónoma De Buenos Aires C1199ABB
    Argentina

    Site Not Available

  • Local Institution - 0047

    Gent, 9000
    Belgium

    Active - Recruiting

  • UZ Gent-Paediatric Nephrology and Rheumatology Department

    Gent, 9000
    Belgium

    Active - Recruiting

  • Local Institution

    Ghent, 9000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, Loire-Atlantique 44093
    France

    Active - Recruiting

  • Bordeaux University Hospital - Pellegrin-Pediatrics

    Bordeaux, 33076
    France

    Active - Recruiting

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique

    Bron, 69677
    France

    Active - Recruiting

  • Hopital De La Timone

    Marseille, 13005
    France

    Active - Recruiting

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita

    Paris, 75019
    France

    Active - Recruiting

  • Hopital Necker

    Paris, 75015
    France

    Active - Recruiting

  • Local Institution - 0057

    Essen, Nordrhein-Westfalen 45122
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, Nordrhein-Westfalen 45122
    Germany

    Active - Recruiting

  • Local Institution - 0011

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Local Institution - 0026

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Local Institution - 0010

    Köln, 50937
    Germany

    Active - Recruiting

  • Local Institution - 0059

    Genova, Liguria 16147
    Italy

    Site Not Available

  • Local Institution

    Milano, 20122
    Italy

    Site Not Available

  • Local Institution - 0030

    Milano, 20122
    Italy

    Site Not Available

  • Local Institution

    Torino, 10126
    Italy

    Site Not Available

  • Local Institution - 0036

    Torino, 10126
    Italy

    Site Not Available

  • Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale

    Torino, 10126
    Italy

    Active - Recruiting

  • Emma Children (AMC)

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Local Institution - 0015

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Local Institution - 0061

    Oslo, N-0027
    Norway

    Site Not Available

  • Local Institution - 0001

    Barcelona, 08035
    Spain

    Completed

  • Local Institution

    Rivas Vaciamadrid, 28523
    Spain

    Active - Recruiting

  • Local Institution - 0012

    Rivas Vaciamadrid, 28523
    Spain

    Completed

  • Local Institution

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Local Institution - 0003

    Sevilla, 41013
    Spain

    Completed

  • Local Institution - 0008

    Manchester, M13 9WL
    United Kingdom

    Completed

  • Local Institution

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Local Institution - 0009

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

  • Local Institution - 0042

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Local Institution - 0041

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCLA Clinical & Translational Research Center (CTRC)-Pediatrics

    Los Angeles, California 90095
    United States

    Site Not Available

  • Local Institution - 0014

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Local Institution - 0022

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Local Institution - 0045

    Miami, Florida 33136
    United States

    Site Not Available

  • Emory Children's Center-Pediatrics

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Local Institution - 0049

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Ann & Robert H. Lurie Children's Hospital of Chicago-Nephrology

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Local Institution - 0033

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Johns Hopkins Hospital-Pediatric Nephrology

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Local Institution - 0017

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Boston Children's Hospital-Division of Nephrology

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Local Institution - 0044

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Local Institution - 0043

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University-Pediatrics

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Duke University-Pediatrics

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Local Institution - 0024

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center-Nephrology

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Local Institution - 0025

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cleveland Clinic-Children's Hospital Pediatric Research Institute

    Cleveland, Ohio 44124
    United States

    Site Not Available

  • Local Institution - 0048

    Cleveland, Ohio 44124
    United States

    Site Not Available

  • Local Institution - 0052

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Science University-Pediatric Nephrology

    Portland, Oregon 97239
    United States

    Site Not Available

  • Local Institution - 0038

    Seattle, Washington 98105
    United States

    Site Not Available

  • Seattle Children's Hospital-Nephrology

    Seattle, Washington 98105
    United States

    Site Not Available

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