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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 - IM103-402

Actualizada: 6 mayo, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 3

    Fase

  • Géneros

  • 12-17

    Rango de edad

  • 12

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap
Biological: Belatacept Drug: Tacrolimus Drug: Cyclosporine A Drug: Mycophenolate Mofetil Drug: Enteric Coated Mycophenolate Sodium Drug: Corticosteroids
Active Comparator: Arm 2: Continue calcineurin inhibitor-based regimen
Drug: Tacrolimus Drug: Cyclosporine A Drug: Corticosteroids Drug: Mycophenolate Mofetil Drug: Enteric Coated Mycophenolate Sodium

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion 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 ≥1 calendar months 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 Exclusion Criteria: - 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

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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