Comparison of three short-course rifamycin-based regimens for the prevention of tuberculosis in patients with end-stage kidney disease: Study protocol for a randomised clinical trial (RIFAKiD-TB trial)

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• dc.contributor.author Santín, Miguel
• dc.contributor.author Perez-Recio, Sandra
• dc.contributor.author Grijota, Maria D.
• dc.contributor.author Anibarro, Luis
• dc.contributor.author Barcala, Jose M.
• dc.contributor.author Souza-Galvao, Maria L. de
• dc.contributor.author Gijon, Paloma
• dc.contributor.author Luque Fernández, Rafael
• dc.contributor.author Sanchez, Francesca
• dc.contributor.author RIFAKiD team trial
• dc.date.accessioned 2023-05-09T06:13:15Z
• dc.date.available 2023-05-09T06:13:15Z
• dc.date.issued 2022
• dc.description.abstract Background and purpose: Screening for and treatment of latent tuberculosis (TB) in patients with end-stage kidney disease (ESKD) are recommended. However, there is limited evidence on safety and treatment completion in this population. The objective of the study is to evaluate three short-course rifamycin-based regimens for the treatment of latent TB in ESKD patients. Methods: Study design and setting. This is a prospective, open label, randomized clinical trial, that will be conducted at seven teaching hospitals in Spain. Study population, randomization, and interventions. Consecutive adult patients with ESKD requiring treatment for a latent TB infection will be randomly allocated (1:1:1) to receive one of the three treatment regimens of the study: three months of daily isoniazid plus rifampicin (3HR); three months of once-weekly isoniazid plus rifapentine (3HP); or four months of daily rifampicin (4R). Participants will be followed regularly through pre-established visits and a blood test schedule from enrolment to a month after finishing the assigned treatment. Outcomes. The primary outcome will be treatment completion, while the secondary outcomes will be discontinuation of the assigned treatment due to adverse events, related or unrelated to the study treatment; definitive discontinuation of the assigned treatment because of adverse events related to the treatment of the study, and death. Sample size. Two hundred and twenty-five subjects (75 per arm) will be enrolled, which will enable the demonstration, if it exists, of an increase of 0.16 in treatment completion rates either in the 3HP or 4R arm with respect to the 3HR arm. Discussion: Results of this clinical trial will contribute to evidence-based recommendations on the management of latent TB infection in ESKD patients. Trial registration: ClinicalTrials.gov identifier: NCT05021731.
• dc.format.mimetype application/pdf
• dc.identifier.citation Santin M, Perez-Recio S, Grijota MD, Anibarro L, Barcala JM, De Souza-Galvao ML, Gijon P, Luque R, Sanchez F; RIFAKiD team trial. Comparison of three short-course rifamycin-based regimens for the prevention of tuberculosis in patients with end-stage kidney disease: Study protocol for a randomised clinical trial (RIFAKiD-TB trial). PLoS One. 2022 Oct 21;17(10):e0276387. DOI: 10.1371/journal.pone.0276387
• dc.identifier.doi http://dx.doi.org/10.1371/journal.pone.0276387
• dc.identifier.issn 1932-6203
• dc.identifier.uri http://hdl.handle.net/10230/56715
• dc.language.iso eng
• dc.publisher Public Library of Science (PLoS)
• dc.relation.ispartof PLoS One. 2022 Oct 21;17(10):e0276387
• dc.rights © 2022 Santin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Isoniazid
• dc.subject.keyword Tuberculosis
• dc.subject.keyword Chronic kidney disease
• dc.subject.keyword Adverse events
• dc.subject.keyword Drug therapy
• dc.subject.keyword Toxicity
• dc.subject.keyword Blood
• dc.subject.keyword Treatment guidelines
• dc.title Comparison of three short-course rifamycin-based regimens for the prevention of tuberculosis in patients with end-stage kidney disease: Study protocol for a randomised clinical trial (RIFAKiD-TB trial)
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion