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Kidney Transplant Study for Adolescents (Ages 12-17)

This study is for adolescents aged 12 to less than 18 who have already received a kidney transplant. Researchers want to compare two different ways of preventing your body from rejecting the new kidney. One way uses a medicine called belatacept, and the other continues with medicines like tacrolimus or cyclosporine A. The study will look at how well these medicines work and if they have any risks. It will also check how well participants take their medicines. The main goal is to see how many participants still have a working kidney after 24 months, with good kidney function. This study plans to enroll 102 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 102 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 24 months post-randomization, suggesting follow-up for at least this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE3Ages 12–17InterventionalTreatment
Bristol-Myers Squibb
~102 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:BelataceptTacrolimusCyclosporine AMycophenolate MofetilEnteric Coated Mycophenolate SodiumCorticosteroids

At a glance

Recruiting sites
15 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who survive with a functional graft with estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2 (updated Schwartz formula) at 24 months post-randomization
Measured over 24 months

Conditions

Renal Allograft Recipients

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Where it's being run

38 sites across 26 states
France5
Germany3
Spain3
Florida2
Ohio2
Italy2
United Kingdom2
Alabama1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 ≥ 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

Exclusion

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

What this trial measures

  • Proportion of participants who survive with a functional graft with estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2 (updated Schwartz formula) at 24 months post-randomization24 months