Actively Recruiting
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 to a Belatacept-based Immunosuppressive Regimen 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
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the benefits and risks of switching adolescent kidney transplant recipients aged 12 to under 18 years from a calcineurin inhibitor-based immunosuppressive regimen to a belatacept-based regimen. The study also evaluates how well these adolescents adhere to their immunosuppressive medications. The trial is a phase 3, open-label, randomized study sponsored by Bristol-Myers Squibb, focusing on a specific patient group with stable kidney function following transplantation. Participants are randomly assigned to one of two groups: one group switches from their current calcineurin inhibitor therapy to belatacept, with a period of overlap followed by tapering off the calcineurin inhibitor; the other group continues their existing calcineurin inhibitor-based treatment. Both groups receive other immunosuppressive drugs such as mycophenolate mofetil, enteric-coated mycophenolate sodium, and corticosteroids as needed. The study monitors participants for up to 24 months after randomization. During the study, participants undergo regular assessments including kidney function tests using estimated glomerular filtration rate (eGFR), monitoring of proteinuria, blood pressure, immunosuppressive medication adherence, and safety laboratory parameters such as lipid and glucose levels. Researchers also track adverse events, graft survival, rejection episodes, and immune responses. The main measure of success is the proportion of participants who maintain a functional kidney graft with adequate eGFR at 24 months. Participants are followed closely throughout the study to gather comprehensive data on treatment effects and adherence.
CONDITIONS
Brief 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 (CNI), with mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium/mycophenolate mofetil (EC-MPS/MPA), with or without daily corticosteroids for 6 30 days prior to randomization
- Clinically stable renal function during the 12-week period prior to screening, in the opinion of the investigator and based on protocol-defined criteria for proteinuria and estimated glomerular filtration rate (eGFR)
- Serologic evidence of past exposure to Epstein-Barr virus (EBV) and current absence of EBV DNA replication at or prior to renal transplantation and during the Screening period
- Completion of an initial course of SARS-CoV-2 vaccination per local standard of care, a minimum of 6 weeks prior to enrollment
You will not qualify if you...
- 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 current allograft
- Banff 97 grade IIA or higher acute cellular rejection (or equivalent), or treatment with plasmapheresis or rituximab for any acute rejection at any time with the current allograft
- Current evidence or past history of active or inadequately treated latent tuberculosis (TB) infection
- Previously treated with belatacept or previously enrolled in a belatacept trial with their present allograft
- Other inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive either a conversion to a belatacept-based immunosuppressive regimen with tapering and discontinuation of calcineurin inhibitors, or continue their calcineurin inhibitor-based regimen.
Regular visits throughout treatment for medication administration and monitoring
Duration - Up to 24 months
Participants are monitored for safety, graft function, medication adherence, and other health outcomes after treatment intervention.
Visits aligned with treatment visits for ongoing assessments
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
F
First line of the email MUST contain NCT # and Site #.
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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