Estudio prospectivo, abierto, multicéntrico, aleatorizado para evaluar los beneficios y riesgos de la conversión de receptores adolescentes de aloinjerto renal de entre 12 y menos de 18 años a un régimen inmunosupresor basado en belatacept en comparación con la continuación de un régimen basado en inhibidores de calcineurina, y su adherencia a los medicamentos inmunosupresores

ReclutandoFase 3ClinicalTrials.gov

ID: NCT04877288Tipo: INTERVENTIONALInicio: 21 de jul de 2021Fin estimado: 30 de jun de 2034

Resumen

El propósito de este estudio es evaluar los beneficios y riesgos de la conversión de receptores adolescentes de aloinjerto renal de entre 12 y menos de 18 años a un régimen inmunosupresor basado en belatacept en comparación con la continuación de un régimen basado en inhibidores de calcineurina, y su adherencia a los medicamentos inmunosupresores.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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