Status:
RECRUITING
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Renal Allograft Recipients
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief 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 immunosuppre...
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
- Other inclusion/exclusion criteria apply
Key Trial Info
Start Date :
July 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2034
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04877288
Start Date
July 21 2021
End Date
June 30 2034
Last Update
November 10 2025
Active Locations (38)
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1
Local Institution - 0042
Birmingham, Alabama, United States, 35233
2
Local Institution - 0041
Los Angeles, California, United States, 90095
3
Local Institution - 0014
Washington D.C., District of Columbia, United States, 20010
4
Local Institution - 0022
Hollywood, Florida, United States, 33021