Efficacy of standard and low dose hydrochlorothiazide in the recurrence prevention of calcium nephrolithiasis (NOSTONE trial): protocol for a randomized double-blind placebo-controlled trial.

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State: Public
Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_959A6A8F0038
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Efficacy of standard and low dose hydrochlorothiazide in the recurrence prevention of calcium nephrolithiasis (NOSTONE trial): protocol for a randomized double-blind placebo-controlled trial.
Journal
BMC nephrology
Author(s)
Dhayat N.A., Faller N., Bonny O., Mohebbi N., Ritter A., Pellegrini L., Bedino G., Schönholzer C., Venzin R.M., Hüsler C., Koneth I., Del Giorno R., Gabutti L., Amico P., Mayr M., Odermatt U., Buchkremer F., Ernandez T., Stoermann-Chopard C., Teta D., Rintelen F., Roumet M., Irincheeva I., Trelle S., Tamò L., Roth B., Vogt B., Fuster D.G.
ISSN
1471-2369 (Electronic)
ISSN-L
1471-2369
Publication state
Published
Issued date
10/12/2018
Peer-reviewed
Oui
Volume
19
Number
1
Pages
349
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: epublish
Abstract
Nephrolithiasis is a global healthcare problem with a current lifetime risk of 18.8% in men and 9.4% in women. Given the high cost of medical treatments and surgical interventions as well as the morbidity related to symptomatic stone disease, medical prophylaxis for stone recurrence is an attractive approach. Thiazide diuretics have been the cornerstone of pharmacologic metaphylaxis for more than 40 years. However, evidence for benefits and harms of thiazides in the prevention of calcium containing kidney stones in general remains unclear. In addition, the efficacy of the currently employed low dose thiazide regimens to prevent stone recurrence is not known.
The NOSTONE trial is an investigator-initiated 3-year prospective, multicenter, double-blind, placebo-controlled trial to assess the efficacy of standard and low dose hydrochlorothiazide treatment in the recurrence prevention of calcium containing kidney stones. We plan to include 416 adult (≥ 18 years) patients with recurrent (≥ 2 stone episodes in the last 10 years) calcium containing kidney stones (containing ≥50% of calcium oxalate, calcium phosphate or a mixture of both). Patients will be randomly allocated to 50 mg or 25 mg or 12.5 mg hydrochlorothiazide or placebo. The primary outcome will be incidence of stone recurrence (a composite of symptomatic or radiologic recurrence). Secondary outcomes will be individual components of the composite primary outcome, safety and tolerability of hydrochlorothiazide treatment, changes in urinary biochemistry elicited by hydrochlorothiazide treatment and impact of baseline disease severity, biochemical abnormalities and stone composition on treatment response.
The NOSTONE study will provide long-sought information on the efficacy of hydrochlorothiazide in the recurrence prevention of calcium containing kidney stones. Strengths of the study include the randomized, double-blind and placebo-controlled design, the large amount of patients studied, the employment of high sensitivity and high specificity imaging and the exclusive public funding support.
ClinicalTrials.gov, NCT03057431 . Registered on February 20 2017.
Keywords
Diuretics/administration & dosage, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Hydrochlorothiazide/administration & dosage, Male, Nephrolithiasis/diagnosis, Nephrolithiasis/drug therapy, Nephrolithiasis/epidemiology, Prospective Studies, Recurrence, Treatment Outcome, Hydrochlorothiazide, Kidney stones, Nephrolithiasis, Prevention
Pubmed
Web of science
Open Access
Yes
Create date
03/01/2019 12:21
Last modification date
08/01/2021 20:14
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