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Trial ID IM103-402  |   NCT04877288

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

Summary

  • Phase 3
  • Male and Female Gender icon
  • 12-17
    Age Range
  • 6
    Locations
  • BMS Recruiting Study icon
    Recruiting

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.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Male and female adolescents 12 to less than 18 years of age
    1. Recipients of a renal allograft from a living or deceased donor transplanted at least 6 calendar months prior to enrollment
      1. 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
        1. 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)
          1. 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
            1. Completion of an initial course of SARS-CoV-2 vaccination per local standard of care, a minimum of 6 weeks prior to enrollment

              Exclusion Criteria

              Exclusion Criteria Icon
              :
              • Recipients with EBV serostatus negative or unknown at screening or at transplant
                1. Treatment for biopsy-proven acute rejection (BPAR) of any degree of severity within 6 calendar months prior to enrollment
                  1. Biopsy-confirmed antibody-mediated acute rejection at any time with the current allograft
                    1. 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
                      1. Current evidence or past history of active or inadequately treated latent tuberculosis (TB) infection
                        1. Previously treated with belatacept or previously enrolled in a belatacept trial with their present allograft Other inclusion/exclusion criteria apply
                          Additional Information *

                          Treatment Options

                          Study Arms

                          ASSIGNED INTERVENTION

                          Study Arms

                          Experimental: Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap

                          ASSIGNED INTERVENTION
                          • Biological: Belatacept
                          • Drug: Tacrolimus, Cyclosporine A, Mycophenolate Mofetil, Enteric Coated Mycophenolate Sodium, Corticosteroids

                          Study Arms

                          Active Comparator: Arm 2: Continue calcineurin inhibitor-based regimen

                          ASSIGNED INTERVENTION
                          • Drug: Tacrolimus, Cyclosporine A, Mycophenolate Mofetil, Enteric Coated Mycophenolate Sodium, Corticosteroids
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