Phase
Condition
N/ATreatment
Mycophenolate Mofetil
Corticosteroids
Tacrolimus
Clinical Study ID
Ages 12-17 All Genders
Study Summary
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
Connect with a study center
Local Institution - 0060
ABB, Buenos Aires F.D. 3433955 C1199ABB
ArgentinaSite Not Available
Local Institution - 0062
Buenos Aires 3435910, 1425
ArgentinaSite Not Available
Local Institution - 0047
Gent, 9000
BelgiumActive - Recruiting
UZ Gent-Paediatric Nephrology and Rheumatology Department
Gent, 9000
BelgiumSite Not Available
Local Institution
Ghent, 9000
BelgiumSite Not Available
UZ Gent-Paediatric Nephrology and Rheumatology Department
Ghent 2797656, 9000
BelgiumActive - Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique 44093
FranceSite Not Available
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes 2990969, Loire-Atlantique 44093
FranceActive - Recruiting
Bordeaux University Hospital - Pellegrin-Pediatrics
Bordeaux, 33076
FranceSite Not Available
Bordeaux University Hospital - Pellegrin-Pediatrics
Bordeaux 3031582, 33076
FranceActive - Recruiting
Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique
Bron, 69677
FranceSite Not Available
Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique
Bron 3029931, 69677
FranceActive - Recruiting
Hopital De La Timone
Marseille, 13005
FranceSite Not Available
Hopital De La Timone
Marseille 2995469, 13005
FranceActive - Recruiting
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
Paris, 75019
FranceSite Not Available
Hopital Necker
Paris, 75015
FranceActive - Recruiting
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
Paris 2988507, 75019
FranceActive - Recruiting
Hopital Necker
Paris 2988507, 75015
FranceActive - Recruiting
Local Institution - 0057
Essen, Nordrhein-Westfalen 45122
GermanySite Not Available
Universitaetsklinikum Essen
Essen, Nordrhein-Westfalen 45122
GermanySite Not Available
Universitaetsklinikum Essen
Essen 2928810, North Rhine-Westphalia 2861876 45122
GermanyActive - Recruiting
Local Institution - 0010
Cologne 2886242, 50937
GermanyActive - Recruiting
Universitaetsklinikum Koeln-Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung für Pädia
Cologne 2886242, 50937
GermanyActive - Recruiting
Local Institution - 0011
Hamburg, 20246
GermanySite Not Available
Local Institution - 0011
Hamburg 2911298, 20246
GermanyActive - Recruiting
Local Institution - 0026
Heidelberg, 69120
GermanySite Not Available
Local Institution - 0026
Heidelberg 2907911, 69120
GermanyActive - Recruiting
Local Institution - 0010
Köln, 50937
GermanySite Not Available
IRCCS Istituto Giannina Gaslini
Genova, Liguria 16147
ItalySite Not Available
Local Institution - 0059
Genova, Liguria 16147
ItalySite Not Available
IRCCS Istituto Giannina Gaslini
Genoa 3176219, Liguria 3174725 16147
ItalyActive - Recruiting
Local Institution - 0030
Milan 6951411, 20122
ItalySite Not Available
Local Institution
Milano, 20122
ItalySite Not Available
Local Institution - 0030
Milano, 20122
ItalySite Not Available
Local Institution
Torino, 10126
ItalySite Not Available
Local Institution - 0036
Torino, 10126
ItalySite Not Available
Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale
Torino, 10126
ItalySite Not Available
Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale
Torino 8980539, 10126
ItalyActive - Recruiting
Emma Children (AMC)
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Local Institution - 0015
Amsterdam, 1105 AZ
NetherlandsActive - Recruiting
Emma Children (AMC)
Amsterdam 2759794, 1105 AZ
NetherlandsActive - Recruiting
Local Institution - 0061
Oslo, N-0027
NorwaySite Not Available
Local Institution - 0061
Oslo 3143244, N-0027
NorwaySite Not Available
Local Institution - 0001
Barcelona, 08035
SpainSite Not Available
Local Institution - 0001
Barcelona 3128760, 08035
SpainCompleted
Local Institution
Rivas Vaciamadrid, 28523
SpainActive - Recruiting
Local Institution - 0012
Rivas Vaciamadrid, 28523
SpainSite Not Available
Local Institution - 0012
Rivas-Vaciamadrid 3107112, 28523
SpainCompleted
Local Institution
Sevilla, 41013
SpainActive - Recruiting
Local Institution - 0003
Sevilla, 41013
SpainSite Not Available
Local Institution - 0003
Seville 2510911, 41013
SpainCompleted
Local Institution - 0008
Manchester, M13 9WL
United KingdomSite Not Available
Local Institution - 0008
Manchester 2643123, M13 9WL
United KingdomCompleted
Local Institution
Nottingham, NG7 2UH
United KingdomSite Not Available
Local Institution - 0009
Nottingham, NG7 2UH
United KingdomActive - Recruiting
Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team
Nottingham, NG7 2UH
United KingdomSite Not Available
Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team
Nottingham 2641170, NG7 2UH
United KingdomActive - Recruiting
Local Institution - 0042
Birmingham, Alabama 35233
United StatesSite Not Available
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama 35233
United StatesSite Not Available
Local Institution - 0042
Birmingham 4049979, Alabama 4829764 35233
United StatesSite Not Available
Local Institution - 0041
Los Angeles, California 90095
United StatesSite Not Available
UCLA Clinical & Translational Research Center (CTRC)-Pediatrics
Los Angeles, California 90095
United StatesSite Not Available
Local Institution - 0041
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Local Institution - 0014
Washington, District of Columbia 20010
United StatesSite Not Available
Local Institution - 0014
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
Local Institution - 0022
Hollywood, Florida 33021
United StatesSite Not Available
Local Institution - 0045
Miami, Florida 33136
United StatesSite Not Available
Local Institution - 0022
Hollywood 4158928, Florida 4155751 33021
United StatesSite Not Available
Local Institution - 0045
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Emory Children's Center-Pediatrics
Atlanta, Georgia 30322
United StatesSite Not Available
Local Institution - 0049
Atlanta, Georgia 30322
United StatesSite Not Available
Local Institution - 0049
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago-Nephrology
Chicago, Illinois 60611
United StatesSite Not Available
Local Institution - 0033
Chicago, Illinois 60611
United StatesSite Not Available
Local Institution - 0033
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Johns Hopkins Hospital-Pediatric Nephrology
Baltimore, Maryland 21287
United StatesSite Not Available
Local Institution - 0017
Baltimore, Maryland 21287
United StatesSite Not Available
Local Institution - 0017
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available
Boston Children's Hospital-Division of Nephrology
Boston, Massachusetts 02115
United StatesSite Not Available
Local Institution - 0044
Boston, Massachusetts 02115
United StatesSite Not Available
Local Institution - 0044
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Local Institution - 0043
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University-Pediatrics
Saint Louis, Missouri 63110
United StatesSite Not Available
Local Institution - 0043
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Duke University-Pediatrics
Durham, North Carolina 27710
United StatesSite Not Available
Local Institution - 0024
Durham, North Carolina 27710
United StatesSite Not Available
Local Institution - 0024
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center-Nephrology
Cincinnati, Ohio 45229
United StatesSite Not Available
Local Institution - 0025
Cincinnati, Ohio 45229
United StatesSite Not Available
Cleveland Clinic-Children's Hospital Pediatric Research Institute
Cleveland, Ohio 44124
United StatesSite Not Available
Local Institution - 0048
Cleveland, Ohio 44124
United StatesSite Not Available
Local Institution - 0025
Cincinnati 4508722, Ohio 5165418 45229
United StatesSite Not Available
Local Institution - 0048
Cleveland 5150529, Ohio 5165418 44124
United StatesSite Not Available
Local Institution - 0052
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health and Science University-Pediatric Nephrology
Portland, Oregon 97239
United StatesSite Not Available
Local Institution - 0052
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Local Institution - 0038
Seattle, Washington 98105
United StatesSite Not Available
Seattle Children's Hospital-Nephrology
Seattle, Washington 98105
United StatesSite Not Available
Local Institution - 0038
Seattle 5809844, Washington 5815135 98105
United StatesSite Not Available

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