Treatment of early borderline lesions in low immunological risk kidney transplant patients : a Spanish multicenter, randomized, controlled parallel-group study protocol: the TRAINING study
Hernández, Domingo (Hospital Regional Universitario de Málaga)
Vázquez-Sánchez, Teresa (Hospital Regional Universitario de Málaga)
Sola, Eugenia (Hospital Regional Universitario de Málaga)
Lopez, Veronica (Hospital Regional Universitario de Málaga)
Ruiz-Esteban, Pedro (Hospital Regional Universitario de Málaga)
Caballero, Abelardo (Hospital Regional Universitario de Málaga)
Salido, Eduardo (Hospital Universitario de Canarias (La Laguna))
León, Myriam (Hospital Regional Universitario de Málaga)
Rodriguez, Aurelio (Hospital Universitario de Canarias (La Laguna))
Serra, Núria (Fundació Puigvert)
Rodriguez, Consuelo (Hospital Universitario de Canarias (La Laguna))
Facundo, Carme (Fundació Puigvert)
Perello, Manel (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Silva, Irene (Fundació Puigvert)
Marrero-Miranda, Domingo (Hospital Universitario de Canarias (La Laguna))
Cidraque, Ignacio (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Moreso, Francesc (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Guirado, Luis (Fundació Puigvert)
Seron, Daniel (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Torres, Armando (Hospital Universitario de Canarias (La Laguna))
Universitat Autònoma de Barcelona

Data:	2022
Resum:	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. : NCT04936282. Registered June 23, 2021, . Protocol Version 2 of 21 January 2022. Sponsor: Canary Isles Institute for Health Research Foundation, Canary Isles (FIISC). mgomez@fciisc. org.
Ajuts:	Ministerio de Economía y Competitividad RD16/0009/0006 Ministerio de Economía y Competitividad RD16/0009/0030 Ministerio de Economía y Competitividad RD16/0009/0031
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Kidney transplant ; Borderline lesions ; Α-klotho, low immunological risk ; Subclinical inflammation
Publicat a:	BMC Nephrology, Vol. 23 (november 2022) , ISSN 1471-2369

DOI: 10.1186/s12882-022-02989-z
PMID: 36344929

10 p, 917.3 KB

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