NCT04877288View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

July 21, 2021

Primary Completion Date

December 30, 2032

Study Completion Date

December 30, 2033

Conditions
Renal Allograft Recipients
Interventions
BIOLOGICAL

Belatacept

Specified dose on specified days

DRUG

Tacrolimus

Specified dose on specified days

DRUG

Cyclosporine A

Specified dose on specified days

DRUG

Mycophenolate Mofetil

Specified dose on specified days

DRUG

Enteric Coated Mycophenolate Sodium

Specified dose on specified days

DRUG

Corticosteroids

Specified dose on Specified days

Trial Locations (38)

1425

NOT_YET_RECRUITING

Local Institution - 0062, Buenos Aires

9000

RECRUITING

UZ Gent-Paediatric Nephrology and Rheumatology Department, Ghent

10126

RECRUITING

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

13005

RECRUITING

Hopital De La Timone, Marseille

16147

RECRUITING

IRCCS Istituto Giannina Gaslini, Genoa

20010

WITHDRAWN

Local Institution - 0014, Washington D.C.

20122

NOT_YET_RECRUITING

Local Institution - 0030, Milan

20246

RECRUITING

Local Institution - 0011, Hamburg

21287

WITHDRAWN

Local Institution - 0017, Baltimore

27710

WITHDRAWN

Local Institution - 0024, Durham

28523

COMPLETED

Local Institution - 0012, Rivas-Vaciamadrid

30322

WITHDRAWN

Local Institution - 0049, Atlanta

33021

WITHDRAWN

Local Institution - 0022, Hollywood

33076

RECRUITING

Bordeaux University Hospital - Pellegrin-Pediatrics, Bordeaux

33136

WITHDRAWN

Local Institution - 0045, Miami

35233

WITHDRAWN

Local Institution - 0042, Birmingham

41013

COMPLETED

Local Institution - 0003, Seville

44093

RECRUITING

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

44124

WITHDRAWN

Local Institution - 0048, Cleveland

45122

RECRUITING

Universitaetsklinikum Essen, Essen

45229

WITHDRAWN

Local Institution - 0025, Cincinnati

50937

RECRUITING

Local Institution - 0010, Cologne

60611

WITHDRAWN

Local Institution - 0033, Chicago

63110

WITHDRAWN

Local Institution - 0043, St Louis

69120

RECRUITING

Local Institution - 0026, Heidelberg

69677

RECRUITING

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

75015

RECRUITING

Hopital Necker, Paris

75019

RECRUITING

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

90095

WITHDRAWN

Local Institution - 0041, Los Angeles

97239

WITHDRAWN

Local Institution - 0052, Portland

98105

WITHDRAWN

Local Institution - 0038, Seattle

02115

WITHDRAWN

Local Institution - 0044, Boston

C1199ABB

NOT_YET_RECRUITING

Local Institution - 0060, ABB

1105 AZ

RECRUITING

Emma Children (AMC), Amsterdam

N-0027

NOT_YET_RECRUITING

Local Institution - 0061, Oslo

08035

COMPLETED

Local Institution - 0001, Barcelona

M13 9WL

COMPLETED

Local Institution - 0008, Manchester

NG7 2UH

RECRUITING

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

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT04877288 - 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 | Biotech Hunter | Biotech Hunter