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

Description

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.

Conditions

Renal Allograft Recipients

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Renal Allograft Recipients
Intervention / Treatment

-

Contacts and Locations

Birmingham

Local Institution - 0042, Birmingham, Alabama, United States, 35233

Los Angeles

Local Institution - 0041, Los Angeles, California, United States, 90095

Washington

Local Institution - 0014, Washington, District of Columbia, United States, 20010

Hollywood

Local Institution - 0022, Hollywood, Florida, United States, 33021

Miami

Local Institution - 0045, Miami, Florida, United States, 33136

Atlanta

Local Institution - 0049, Atlanta, Georgia, United States, 30322

Chicago

Local Institution - 0033, Chicago, Illinois, United States, 60611

Baltimore

Local Institution - 0017, Baltimore, Maryland, United States, 21287

Boston

Local Institution - 0044, Boston, Massachusetts, United States, 02115

Saint Louis

Local Institution - 0043, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2031-12-30