Summary

Eligibility
for people ages 12-17 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Renal Allograft Recipients, Acute rejection, Belatacept, Calcineurin inhibitors (cyclosporine, tacrolimus), Conversion, Donor-specific antibodies, eGFR, Immunosuppressive regimen, Adolescent kidney transplant recipients, Cyclosporine, Mycophenolic Acid, Abatacept, Tacrolimus, Cyclosporins, Cyclosporine A, Mycophenolate Mofetil, Enteric Coated Mycophenolate Sodium, Corticosteroids

Eligibility

You can join if…

Open to people ages 12-17

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Clinical & Translational Research Center (CTRC)-Pediatrics not yet accepting patients
    Los Angeles California 90095 United States
  • Oregon Health and Science University-Pediatric Nephrology not yet accepting patients
    Portland Oregon 97239 United States
  • Local Institution - 0008 accepting new patients
    Manchester M13 9WL United Kingdom
  • Local Institution - 0009 accepting new patients
    Nottingham NG7 2UH United Kingdom

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT04877288
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 102 study participants
Last Updated