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

Talk to us

Conditions

Renal Allograft RecipientsAcute rejectionBelataceptCalcineurin inhibitors (cyclosporine, tacrolimus)ConversionDonor-specific antibodieseGFRImmunosuppressive regimenAdolescent kidney transplant recipients

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2021-07-21
Study Completion:2031-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04877288

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.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Male and female adolescents 12 to less than 18 years of age
  2. * Recipients of a renal allograft from a living or deceased donor transplanted at least 6 calendar months prior to enrollment
  3. * 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
  4. * 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)
  5. * 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
  6. * Completion of an initial course of SARS-CoV-2 vaccination per local standard of care, a minimum of 6 weeks prior to enrollment
  1. * Recipients with EBV serostatus negative or unknown at screening or at transplant
  2. * Treatment for biopsy-proven acute rejection (BPAR) of any degree of severity within 6 calendar months prior to enrollment
  3. * Biopsy-confirmed antibody-mediated acute rejection at any time with the current allograft
  4. * 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
  5. * Current evidence or past history of active or inadequately treated latent tuberculosis (TB) infection
  6. * Previously treated with belatacept or previously enrolled in a belatacept trial with their present allograft

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0042
Birmingham, Alabama, 35233
United States
Local Institution - 0041
Los Angeles, California, 90095
United States
Local Institution - 0014
Washington, District of Columbia, 20010
United States
Local Institution - 0022
Hollywood, Florida, 33021
United States
Local Institution - 0045
Miami, Florida, 33136
United States
Local Institution - 0049
Atlanta, Georgia, 30322
United States
Local Institution - 0033
Chicago, Illinois, 60611
United States
Local Institution - 0017
Baltimore, Maryland, 21287
United States
Local Institution - 0044
Boston, Massachusetts, 02115
United States
Local Institution - 0043
Saint Louis, Missouri, 63110
United States
Local Institution - 0024
Durham, North Carolina, 27710
United States
Local Institution - 0025
Cincinnati, Ohio, 45229
United States
Local Institution - 0048
Cleveland, Ohio, 44124
United States
Local Institution - 0052
Portland, Oregon, 97239
United States
Local Institution - 0038
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-21
Study Completion Date2031-12-30

Study Record Updates

Study Start Date2021-07-21
Study Completion Date2031-12-30

Terms related to this study

Keywords Provided by Researchers

  • Acute rejection
  • Belatacept
  • Calcineurin inhibitors (cyclosporine, tacrolimus)
  • Conversion
  • Donor-specific antibodies
  • eGFR
  • Immunosuppressive regimen
  • Adolescent kidney transplant recipients

Additional Relevant MeSH Terms

  • Renal Allograft Recipients