Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients

The impact of corticosteroid withdrawal on medium-term graft histological changes in kidney transplant (KT) recipients under standard immunosuppression is uncertain. As part of an open-label, multicenter, prospective, phase IV, 24-month clinical trial (ClinicalTrials.gov, NCT02284464) in low-immunol...

Descripción completa

Detalles Bibliográficos
Autores: Hernández, Domingo, Alonso-Titos, Juana, Vázquez, Teresa, León, Myriam, Caballero, Abelardo, Cobo, María Angeles, Sola, Eugenia, López, Verónica, Ruiz-Esteban, Pedro, Cruzado, Josep María, Sellarés, Joana, Moreso, Francesc, Manonelles, Anna, Torío, Alberto, Cabello, Mercedes, Delgado-Burgos, Juan, Casas, Cristina, Gutiérrez, Elena, Jironda, Cristina, Kanter, Julia, Serón, Daniel, Torres, Armando
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/18334
Acceso en línea:http://hdl.handle.net/20.500.12105/18334
Access Level:acceso abierto
Palabra clave:Subclinical inflammation
Kidney transplant
Protocol biopsy
Corticosteroids withdrawal
Low immunological risk
Rejection
Borderline lesions
Chronic graft histological changes
Rechazo
Corticoesteroides
Trasplante de riñón
Blood pressure
Presión sanguínea
Terapia de inmunosupresión
Inflamación
Humans
Tacrolimus
Kidney Transplantation
Prospective Studies
Blood Pressure
Immunosuppression
Adrenal Cortex Hormones
Allografts
Biopsy
Inflammation
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
Clinical Trials, Phase IV as Topic
Descripción
Sumario:The impact of corticosteroid withdrawal on medium-term graft histological changes in kidney transplant (KT) recipients under standard immunosuppression is uncertain. As part of an open-label, multicenter, prospective, phase IV, 24-month clinical trial (ClinicalTrials.gov, NCT02284464) in low-immunological-risk KT recipients, 105 patients were randomized, after a protocol-biopsy at 3 months, to corticosteroid continuation (CSC, n = 52) or corticosteroid withdrawal (CSW, n = 53). Both groups received tacrolimus and MMF and had another protocol-biopsy at 24 months. The acute rejection rate, including subclinical inflammation (SCI), was comparable between groups (21.2 vs. 24.5%). No patients developed dnDSA. Inflammatory and chronicity scores increased from 3 to 24 months in patients with, at baseline, no inflammation (NI) or SCI, regardless of treatment. CSW patients with SCI at 3 months had a significantly increased chronicity score at 24 months. HbA1c levels were lower in CSW patients (6.4 ± 1.2 vs. 5.7 ± 0.6%; p = 0.013) at 24 months, as was systolic blood pressure (134.2 ± 14.9 vs. 125.7 ± 15.3 mmHg; p = 0.016). Allograft function was comparable between groups and no patients died or lost their graft. An increase in chronicity scores at 2-years post-transplantation was observed in low-immunological-risk KT recipients with initial NI or SCI, but CSW may accelerate chronicity changes, especially in patients with early SCI. This strategy did, however, improve the cardiovascular profiles of patients.

Similares en LA Referencia