2026-08-29T14:07:53Zhttps://repisalud.isciii.es/rest/oai/request
oai:repisalud.isciii.es:20.500.12105/188482024-09-21T20:48:02Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16927
Repisalud author Hernández, Domingo author Vázquez-Sánchez, Teresa author Sola, Eugenia author Lopez, Veronica author Ruiz-Esteban, Pedro author Caballero, Abelardo author Salido, Eduardo author Leon, Myriam author Rodriguez, Aurelio author Serra, Nuria author Rodriguez, Consuelo author Facundo, Carme author Perello, Manel author Silva, Irene author Marrero-Miranda, Domingo author Cidraque, Ignacio author Moreso, Francesc author Guirado, Luis author Serón, Daniel author Torres, Armando 2024-02-27T15:24:32Z 2024-02-27T15:24:32Z 2022-11-07 10.1186/s12882-022-02989-z 1471-2369 BMC nephrology http://hdl.handle.net/10668/20273 36344929 http://hdl.handle.net/20.500.12105/18848 Subclinical inflammation, including borderline lesions (BL), is very common (30-40%) after kidney transplantation (KT), even in low immunological risk patients, and can lead to interstitial fibrosis/tubular atrophy (IFTA) and worsening of renal function with graft loss. Few controlled studies have analyzed the therapeutic benefit of treating these BL on renal function and graft histology. Furthermore, these studies have only used bolus steroids, which may be insufficient to slow the progression of these lesions. Klotho, a transmembrane protein produced mainly in the kidney with antifibrotic properties, plays a crucial role in the senescence-inflammation binomial of kidney tissue. Systemic and local inflammation decrease renal tissue expression and soluble levels of α-klotho. It is therefore important to determine whether treatment of BL prevents a decrease in α-klotho levels, progression of IFTA, and loss of kidney function. The TRAINING study will randomize 80 patients with low immunological risk who will receive their first KT. The aim of the study is to determine whether the treatment of early BL (3rd month post-KT) with polyclonal rabbit antithymocyte globulin (Grafalon®) (6 mg/kg/day) prevents or decreases the progression of IFTA and the worsening of graft function compared to conventional therapy after two years post-KT, as well as to analyze whether treatment of BL with Grafalon® can modify the expression and levels of klotho, as well as the pro-inflammatory cytokines that regulate its expression. This phase IV investigator-driven, randomized, placebo-controlled clinical trial will examine the efficacy and safety of Grafalon® treatment in low-immunological-risk KT patients with early BL. clinicaltrials.gov : NCT04936282. Registered June 23, 2021, https://clinicaltrials.gov/ct2/show/NCT04936282?term=NCT04936282&draw=2&rank=1 . Protocol Version 2 of 21 January 2022. Canary Isles Institute for Health Research Foundation, Canary Isles (FIISC). mgomez@fciisc.org . eng borderline lesions kidney transplant subclinical inflammation α-klotho, low immunological risk Treatment of early borderline lesions in low immunological risk kidney transplant patients: a Spanish multicenter, randomized, controlled parallel-group study protocol: the TRAINING study. research article