HYDROchlorothiazide versus placebo to PROTECT polycystic kidney disease patients and improve their quality of life : study protocol and rationale for the HYDRO-PROTECT randomized controlled trial
Bais, Thomas (University Medical Center Groningen)
Meijer, Esther (University Medical Center Groningen)
Kramers, Bart J. (University Medical Center Groningen)
Vart, Priya (University Medical Center Groningen)
Vervloet, Marc (Amsterdam University Medical Center (UMC))
Salih, Mahdi (Erasmus University Medical Center)
Bammens, Bert (UZ Leuven)
Demoulin, Nathalie (Cliniques Universitaires Saint-Luc)
Todorova, Polina (University of Cologne)
Müller, Roman-Ulrich (University of Cologne)
Halbritter, Jan (Charité-Universitätsmedizin Berlin)
Paliege, Alexander (Universitätsklinikum Carl Gustav Carus)
Cornec-Le Gall, Emilie (CHRU Brest)
Knebelmann, Bertrand (Necker-Enfants Malades Hospital AP-HP)
Torra Balcells, Roser (Institut de Recerca Sant Pau)
Ong, Albert C. M. (University of Sheffield)
Karet Frankl, Fiona E. (University of Cambridge)
Gansevoort, Ron T. (University Medical Center Groningen)
Universitat Autònoma de Barcelona

Fecha:	2024
Resumen:	Autosomal dominant polycystic kidney disease (ADPKD) leads to progressive renal cyst formation and loss of kidney function in most patients. Vasopressin 2 receptor antagonists (V2RA) like tolvaptan are currently the only available renoprotective agents for rapidly progressive ADPKD. However, aquaretic side effects substantially limit their tolerability and therapeutic potential. In a preliminary clinical study, the addition of hydrochlorothiazide (HCT) to tolvaptan decreased 24-h urinary volume and appeared to increase renoprotective efficacy. The HYDRO-PROTECT study will investigate the long-term effect of co-treatment with HCT on tolvaptan efficacy (rate of kidney function decline) and tolerability (aquaresis and quality of life) in patients with ADPKD. The HYDRO-PROTECT study is an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized clinical trial. The study is powered to enroll 300 rapidly progressive patients with ADPKD aged ≥ 18 years, with an eGFR of.
Derechos:	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.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Antidiuretic Hormone Receptor Antagonists ; Glomerular Filtration Rate ; Humans ; Hydrochlorothiazide ; Kidney ; Multicenter Studies as Topic ; Polycystic Kidney, Autosomal Dominant ; Quality of Life ; Randomized Controlled Trials as Topic ; Tolvaptan
Publicado en:	Trials, Vol. 25 Núm. 1 (december 2024) , p. 120, ISSN 1745-6215

DOI: 10.1186/s13063-024-07952-x
PMID: 38355627

12 p, 1.1 MB

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