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NCT04877288PHASE3Recruiting

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

Bristol-Myers Squibb

Start Date

7/21/2021

Completion Date

6/30/2034

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

Age Range: 12 years to 17 years

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

Interventions

BIOLOGICAL

Belatacept

DRUG

Tacrolimus

DRUG

Cyclosporine A

DRUG

Mycophenolate Mofetil

DRUG

Enteric Coated Mycophenolate Sodium

DRUG

Corticosteroids

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Conditions

Renal Allograft Recipients

Locations

Local Institution - 0042

Birmingham, Alabama 35233

United States

Local Institution - 0041

Los Angeles, California 90095

United States

Local Institution - 0014

Washington D.C., District of Columbia 20010

United States

Local Institution - 0022

Hollywood, Florida 33021

United States

Local Institution - 0045

Miami, Florida 33136

United States

Local Institution - 0049

Atlanta, Georgia 30322

United States

Local Institution - 0033

Chicago, Illinois 60611

United States

Local Institution - 0017

Baltimore, Maryland 21287

United States

Local Institution - 0044

Boston, Massachusetts 02115

United States

Local Institution - 0043

St Louis, Missouri 63110

United States

Local Institution - 0024

Durham, North Carolina 27710

United States

Local Institution - 0025

Cincinnati, Ohio 45229

United States

Local Institution - 0048

Cleveland, Ohio 44124

United States

Local Institution - 0052

Portland, Oregon 97239

United States

Local Institution - 0038

Seattle, Washington 98105

United States

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D. C1199ABB

Argentina

Local Institution - 0062

Buenos Aires, 1425

Argentina

UZ Gent-Paediatric Nephrology and Rheumatology Department

Ghent, 9000

Belgium

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

Nantes, Loire-Atlantique 44093

France

Bordeaux University Hospital - Pellegrin-Pediatrics

Bordeaux, 33076

France

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

Bron, 69677

France

Hopital De La Timone

Marseille, 13005

France

Hopital Necker

Paris, 75015

France

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

Paris, 75019

France

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia 45122

Germany

Universitaetsklinikum Koeln-Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung für Pädia

Cologne, 50937

Germany

Local Institution - 0011

Hamburg, 20246

Germany

Local Institution - 0026

Heidelberg, 69120

Germany

IRCCS Istituto Giannina Gaslini

Genoa, Liguria 16147

Italy

Local Institution - 0030

Milan, 20122

Italy

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

Torino, 10126

Italy

Emma Children (AMC)

Amsterdam, 1105 AZ

Netherlands

Local Institution - 0061

Oslo, N-0027

Norway

Local Institution - 0001

Barcelona, 08035

Spain

Local Institution - 0012

Rivas-Vaciamadrid, 28523

Spain

Local Institution - 0003

Seville, 41013

Spain

Local Institution - 0008

Manchester, M13 9WL

United Kingdom

Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team

Nottingham, NG7 2UH

United Kingdom