%0 Journal Article
%A Hernández, Domingo
%A Alonso-Titos, Juana
%A Vázquez, Teresa
%A León, Myriam
%A Caballero, Abelardo
%A Cobo, María Angeles
%A Sola, Eugenia
%A López, Verónica
%A Ruiz-Esteban, Pedro
%A Cruzado, Josep María
%A Sellarés, Joana
%A Moreso, Francesc
%A Manonelles, Anna
%A Torío, Alberto
%A Cabello, Mercedes
%A Delgado-Burgos, Juan
%A Casas, Cristina
%A Gutiérrez, Elena
%A Jironda, Cristina
%A Kanter, Julia
%A Serón, Daniel
%A Torres, Armando
%T Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients
%D 2021
%U http://hdl.handle.net/10668/4055
%X 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.
%K Subclinical inflammation
%K Kidney transplant
%K Protocol biopsy
%K Corticosteroids withdrawal
%K Low immunological risk
%K Rejection
%K Borderline lesions
%K Chronic graft histological changes
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