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.

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
14 Feb 2024
Historique:
received: 18 07 2023
accepted: 24 01 2024
medline: 15 2 2024
pubmed: 15 2 2024
entrez: 14 2 2024
Statut: epublish

Résumé

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 > 25 mL/min/1.73 m The primary study outcome is the rate of kidney function decline (expressed as eGFR slope, in mL/min/1.73 m The HYDRO-PROTECT study will demonstrate whether co-treatment with HCT can improve the renoprotective efficacy and tolerability of tolvaptan in patients with ADPKD.

Sections du résumé

BACKGROUND BACKGROUND
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.
METHODS METHODS
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 > 25 mL/min/1.73 m
OUTCOMES RESULTS
The primary study outcome is the rate of kidney function decline (expressed as eGFR slope, in mL/min/1.73 m
CONCLUSION CONCLUSIONS
The HYDRO-PROTECT study will demonstrate whether co-treatment with HCT can improve the renoprotective efficacy and tolerability of tolvaptan in patients with ADPKD.

Identifiants

DOI: 10.1186/s13063-024-07952-x PMID: 38355627
pubmed: 38355627
doi: 10.1186/s13063-024-07952-x
pii: 10.1186/s13063-024-07952-x
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

120

Subventions

Organisme : ZonMw
ID : 10140022010010
Pays : Netherlands

Informations de copyright

© 2024. The Author(s).

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Auteurs

Thomas Bais (T)

Department of Nephrology, University Medical Center Groningen, Groningen, The Netherlands.

Esther Meijer (E)

Department of Nephrology, University Medical Center Groningen, Groningen, The Netherlands.
ORCID: 0000-0001-7875-1793

Bart J Kramers (BJ)

Department of Nephrology, University Medical Center Groningen, Groningen, The Netherlands.

Priya Vart (P)

Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.

Marc Vervloet (M)

Department of Nephrology, Amsterdam University Medical Centers, Location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Mahdi Salih (M)

Department of Internal Medicine, Division of Nephrology and Transplantation, Erasmus University Medical Center, Rotterdam, The Netherlands.

Bert Bammens (B)

Department of Nephrology, Dialysis and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium.

Nathalie Demoulin (N)

Division of Nephrology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.

Polina Todorova (P)

University of Cologne, Faculty of Medicine and University Hospital Cologne, Department 2 for Internal Medicine, Cologne, Germany.

Roman-Ulrich Müller (RU)

University of Cologne, Faculty of Medicine and University Hospital Cologne, Department 2 for Internal Medicine, Cologne, Germany.

Jan Halbritter (J)

Department of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany.

Alexander Paliege (A)

Department of Nephrology, Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Germany.

Emilie Cornec-Le Gall (EC)

University Brest, Inserm, UMR 1078, GGB, Brest, 29609, France.
Service de Néphrologie, Hémodialyse et Transplantation Rénale, CHRU Brest, Brest, 29609, France.

Bertrand Knebelmann (B)

Department of Nephrology, Necker-Enfants Malades Hospital AP-HP, Paris, France.

Roser Torra (R)

Inherited Kidney Diseases, Nephrology Department, Fundació Puigvert, Institut d'Investigació Biomèdica Sant Pau (IIB-SANT PAU), Barcelona, Spain.

Albert C M Ong (ACM)

Academic Nephrology Unit, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.

Fiona E Karet Frankl (FE)

Department of Medical Genetics and Division of Renal Medicine, University of Cambridge, Cambridge, UK.

Ron T Gansevoort (RT)

Department of Nephrology, University Medical Center Groningen, Groningen, The Netherlands. r.t.gansevoort@umcg.nl.
Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, PO Box 30.001, 9700, RB, Groningen, The Netherlands. r.t.gansevoort@umcg.nl.

Classifications MeSH