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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
Sponsor: Bristol-Myers Squibb
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.
Official title: 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
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2021-07-21
Completion Date
2034-06-30
Last Updated
2026-02-03
Healthy Volunteers
No
Conditions
Interventions
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
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
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
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