RecruitingPhase 3NCT04877288

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

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

Sponsor

Bristol-Myers Squibb

Enrollment

102 participants

Start Date

Jul 21, 2021

Study Type

INTERVENTIONAL

Conditions

Renal Allograft Recipients

Summary

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.

Eligibility

Min Age: 12 YearsMax Age: 17 Years

Inclusion Criteria6

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 Criteria6

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

Interested in this trial?

Get notified about updates and connect with the research team.