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RecruitingPhase 3NCT04877288

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

A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal 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

Sponsor

Bristol-Myers Squibb

Enrollment

102 participants

Start Date

Jul 21, 2021

Study Type

INTERVENTIONAL

Conditions

Renal Allograft Recipients

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

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Belatacept, a drug called Corticosteroids, and others for people with renal allograft recipients. The study is currently recruiting participants at 38 locations. People eligible for this study include aged 12 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBelatacept

Specified dose on specified days

DRUGTacrolimus

Specified dose on specified days

DRUGCyclosporine A

Specified dose on specified days

DRUGMycophenolate Mofetil

Specified dose on specified days

DRUGEnteric Coated Mycophenolate Sodium

Specified dose on specified days

DRUGCorticosteroids

Specified dose on Specified days

Locations(38)

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

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., Argentina

Instituto de Trasplantes y Alta Complejidad

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

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

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

View Full Details on ClinicalTrials.gov

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NCT04877288

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