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

Dhayat, Nasser; Faller, Nicolas; Rintelen, Felix; Roumet, Marie Camille; Irincheeva, Irina; Trelle, Sven; Tamò, Luca; Roth, Beat; Vogt, Bruno; Fuster, Daniel G (2018). 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. BMC nephrology, 19(1), p. 349. BioMed Central 10.1186/s12882-018-1144-6

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Background: 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. Methods: 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. Discussion: 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. Trial registration: ClinicalTrials.gov, NCT03057431. Registered on February 20 2017.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Nephrology and Hypertension
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern
04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Urology
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Unit Childrens Hospital > Forschungsgruppe Nephrologie / Hypertonie

UniBE Contributor:

Dhayat, Nasser; Faller, Nicolas; Rintelen, Felix; Roumet, Marie Camille; Irincheeva, Irina; Trelle, Sven; Tamò, Luca Giuseppe Athos; Roth, Beat; Vogt, Bruno and Fuster, Daniel Guido

Subjects:

600 Technology > 610 Medicine & health
500 Science > 570 Life sciences; biology
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1471-2369

Publisher:

BioMed Central

Language:

English

Submitter:

Nasser Dhayat

Date Deposited:

18 Dec 2018 09:36

Last Modified:

20 Dec 2018 11:31

Publisher DOI:

10.1186/s12882-018-1144-6

PubMed ID:

30526528

Additional Information:

Kollaboration. Es sind nur die Berner Autoren verknüpft.

Uncontrolled Keywords:

Nephrolithiasis, Kidney stones, Recurrence, Prevention, Hydrochlorothiazide

BORIS DOI:

10.7892/boris.121954

URI:

https://boris.unibe.ch/id/eprint/121954

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