Evaluating a new immunosuppressive regimen for adolescent kidney transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Italiano de Buenos Aires
  Abb, Buenos Aires F.D., Argentina Recruiting
• Instituto de Trasplantes y Alta Complejidad
  Buenos Aires, Argentina Recruiting
• UZ Gent-Paediatric Nephrology and Rheumatology Department
  Ghent, Belgium Recruiting
• Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
  Nantes, Loire-Atlantique, France Recruiting
• Bordeaux University Hospital - Pellegrin-Pediatrics
  Bordeaux, France Recruiting
• Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique
  Bron, France Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.