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Authors
Nieto-Elizalde, Julia
Zaballos, Matilde https://orcid.org/0000-0002-1398-8965
González-Nicolas, María Ángeles https://orcid.org/0000-0002-3514-4616
Lozano Lominchar, Pablo https://orcid.org/0000-0002-5413-8449
Palencia-García, Natividad https://orcid.org/0000-0002-9320-2423
Fernández-Vázquez, María Luz https://orcid.org/0000-0001-7630-4543
Vázquez-Ogando, Elena https://orcid.org/0000-0002-5996-5208
Canal, María Iluminada
Lázaro, Alberto https://orcid.org/0000-0002-1095-679X
González Bayón, Luis https://orcid.org/0000-0002-2543-197X
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Funding
Funding for this research was provided by:
Spanish Ministry of Economy and Competitiveness Instituto de Salud Carlos III-Fondo de Investigación en Salud (ICI21/00111)
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Article History
Received: 18 May 2026
Accepted: 19 August 2026
First Online: 8 September 2026
Declarations
Ethics approval and consent to participate: The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki (World Medical Association, Fortaleza, 2013), the International Council for Harmonisation Good Clinical Practice guidelines (ICH-GCP E6 [R2]), and applicable regulatory requirements, including Regulation (EU) No 536/2014 and Spanish Royal Decree 1090/2015. The protocol has been approved by the Research Ethics Committee (Comité de Ética de la Investigación con Medicamentos, CEIm) of Hospital General Universitario Gregorio Marañón (20 February, 2023) and by the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) under the reference code MUH/CLIN/EC. Written informed consent will be obtained from all participants prior to any study-related procedures. Study results will be disseminated through peer-reviewed publications and reporting in clinical trial registries, in accordance with regulatory requirements. Participants will not be individually identifiable in any dissemination materials.
Consent for publication: Not applicable.
Competing interests: AL is coinventor of several patents on the use of cilastatin as a nephroprotector (“Use of cilastatin to reduce nephrotoxicity of various compounds,” patent numbers: EP 2143429 B1; US 9,216,185 B2; US 9,522,128 B2; and US 9,757,349 B2). AL and MAG-N are coinventors on the use of cilastatin as treatment in sepsis and in sepsis-induced acute kidney failure (“Cilastatin for use in the treatment of sepsis,” patent numbers: EP 3474897 B1; US 11,185,522 B2; JP 7109791. B2; CN 109843330 B; CA3028846 A1, and AU 20177281744 B2). These were assigned to Fundación para la Investigación Biomédica del Hospital Gregorio Marañón (FIBHGM), licensed to Telara Pharma S.L., and transferred to Arch Biopartners. AL is a cofounder of Telara Pharma S.L. AL and MAG-N are stockholders of Telara Pharma S.L. The other authors declare that they have no competing interests.
