Home › Trials › NCT04877288

Evaluating a new immunosuppressive regimen for adolescent kidney transplant recipients

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 of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

Phase 3 Interventional Bristol-Myers Squibb · NCT04877288

This study is testing whether switching adolescent kidney transplant recipients from their current medication to a new one called belatacept can improve their kidney function and overall health.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment102 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsrituximab
Locations38 sites (Birmingham, Alabama and 37 other locations)
Trial IDNCT04877288 on ClinicalTrials.gov

What this trial studies

This study 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. Participants will be monitored for adherence to their immunosuppressive medications and overall renal function. The study will compare outcomes between those who continue with their current regimen and those who switch to belatacept. The research is designed to provide insights into the effectiveness and safety of this conversion in managing kidney transplant recipients.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents aged 12 to less than 18 years who have received a kidney transplant at least 6 months prior and are currently stable on a calcineurin inhibitor regimen.

Not a fit: Patients who are not kidney transplant recipients or those who have not been stable on their current immunosuppressive regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved immunosuppressive strategies that enhance kidney transplant outcomes in adolescents.

How similar studies have performed: Previous studies have shown promising results with belatacept in adult populations, but this specific approach in adolescents is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 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 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

Where this trial is running

Birmingham, Alabama and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Renal Allograft RecipientsAcute rejectionBelataceptCalcineurin inhibitorsConversionDonor-specific antibodieseGFRImmunosuppressive regimen
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.