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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8125434/ https://www.ncbi.nlm.nih.gov/pubmed/34067039 http://dx.doi.org/10.3390/jcm10092005 |
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author | 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 |
author_facet | 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 |
author_sort | Hernández, Domingo |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8125434 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-81254342021-05-17 Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients 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 J Clin Med Article 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. MDPI 2021-05-07 /pmc/articles/PMC8125434/ /pubmed/34067039 http://dx.doi.org/10.3390/jcm10092005 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article 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 Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients |
title | Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients |
title_full | Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients |
title_fullStr | Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients |
title_full_unstemmed | Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients |
title_short | Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients |
title_sort | clinical relevance of corticosteroid withdrawal on graft histological lesions in low-immunological-risk kidney transplant patients |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8125434/ https://www.ncbi.nlm.nih.gov/pubmed/34067039 http://dx.doi.org/10.3390/jcm10092005 |
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