Actively Recruiting
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
Led by Bristol-Myers Squibb · Updated on 2026-02-03
102
Participants Needed
38
Research Sites
675 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with mycophenolate mofetil or enteric-coated mycophenolate sodium/mycophenolate mofetil, with or without daily corticosteroids for at least 30 days prior to randomization
- Clinically stable renal function during the 12-week period prior to screening based on proteinuria and estimated glomerular filtration rate
- Serologic evidence of past Epstein-Barr virus exposure and no active EBV DNA replication at or before transplantation and during screening
- Completed an initial course of SARS-CoV-2 vaccination at least 6 weeks prior to enrollment
You will not qualify if you...
- Epstein-Barr virus serostatus negative or unknown at screening or transplant
- Treatment for biopsy-proven acute rejection within 6 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 treatment with plasmapheresis or rituximab for any acute rejection with the current allograft
- Current evidence or past history of active or inadequately treated latent tuberculosis infection
- Previously treated with belatacept or previously enrolled in a belatacept trial with the current allograft
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 38 locations
1
Local Institution - 0042
Birmingham, Alabama, United States, 35233
Withdrawn
2
Local Institution - 0041
Los Angeles, California, United States, 90095
Withdrawn
3
Local Institution - 0014
Washington D.C., District of Columbia, United States, 20010
Withdrawn
4
Local Institution - 0022
Hollywood, Florida, United States, 33021
Withdrawn
5
Local Institution - 0045
Miami, Florida, United States, 33136
Withdrawn
6
Local Institution - 0049
Atlanta, Georgia, United States, 30322
Withdrawn
7
Local Institution - 0033
Chicago, Illinois, United States, 60611
Withdrawn
8
Local Institution - 0017
Baltimore, Maryland, United States, 21287
Withdrawn
9
Local Institution - 0044
Boston, Massachusetts, United States, 02115
Withdrawn
10
Local Institution - 0043
St Louis, Missouri, United States, 63110
Withdrawn
11
Local Institution - 0024
Durham, North Carolina, United States, 27710
Withdrawn
12
Local Institution - 0025
Cincinnati, Ohio, United States, 45229
Withdrawn
13
Local Institution - 0048
Cleveland, Ohio, United States, 44124
Withdrawn
14
Local Institution - 0052
Portland, Oregon, United States, 97239
Withdrawn
15
Local Institution - 0038
Seattle, Washington, United States, 98105
Withdrawn
16
Local Institution - 0060
ABB, Buenos Aires F.D., Argentina, C1199ABB
Not Yet Recruiting
17
Local Institution - 0062
Buenos Aires, Argentina, 1425
Not Yet Recruiting
18
UZ Gent-Paediatric Nephrology and Rheumatology Department
Ghent, Belgium, 9000
Actively Recruiting
19
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, France, 44093
Actively Recruiting
20
Bordeaux University Hospital - Pellegrin-Pediatrics
Bordeaux, France, 33076
Actively Recruiting
21
Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique
Bron, France, 69677
Actively Recruiting
22
Hopital De La Timone
Marseille, France, 13005
Actively Recruiting
23
Hopital Necker
Paris, France, 75015
Actively Recruiting
24
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
Paris, France, 75019
Actively Recruiting
25
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany, 45122
Actively Recruiting
26
Universitaetsklinikum Koeln-Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung für Pädia
Cologne, Germany, 50937
Actively Recruiting
27
Local Institution - 0011
Hamburg, Germany, 20246
Actively Recruiting
28
Local Institution - 0026
Heidelberg, Germany, 69120
Actively Recruiting
29
IRCCS Istituto Giannina Gaslini
Genoa, Liguria, Italy, 16147
Actively Recruiting
30
Local Institution - 0030
Milan, Italy, 20122
Withdrawn
31
Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale
Torino, Italy, 10126
Actively Recruiting
32
Emma Children (AMC)
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
33
Local Institution - 0061
Oslo, Norway, N-0027
Withdrawn
34
Local Institution - 0001
Barcelona, Spain, 08035
Completed
35
Local Institution - 0012
Rivas-Vaciamadrid, Spain, 28523
Completed
36
Local Institution - 0003
Seville, Spain, 41013
Completed
37
Local Institution - 0008
Manchester, United Kingdom, M13 9WL
Completed
38
Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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