NOSTONE Trial: Recruitment open!
In August 2015, the Swiss National Science Foundation launched the first call to fund Investigator Initiated Clinical Trials (IICT). One of these first round funded IICTs is the NOSTONE trial, which is supported by the CTU Bern.
The NOSTONE clinical trial is a multicenter, randomized, placebo-controlled, double-blind, parallel-group trial with the purpose to assess the efficacy of standard and low dose of hydrochlorothiazide (HCTZ) in the recurrence prevention of calcium-containing kidney stones. HCTZ 12.5 mg, 25 mg, 50 mg or placebo will be given once daily per os for 24 or 36 months to patients who had at least 2 kidney stones in the past 10 years. In addition, all patients will receive state-of-the-art non-pharmacologic recommendations for stone prevention according to current guidelines.
The investigators aim to assess the dose-response relationship for three different dosages of HCTZ on of the incidence of stone recurrences (a composite of symptomatic or radiologic recurrence). At the beginning and at the end of the trial, the presence and dimension of kidney stones will be assed using low-dose CT.
416 patients in total (104 patients per study arm) will be enrolled at 12 sites in Switzerland including University Hospitals of Basel, Bern, Geneva, Lausanne and Zürich as well as Cantonal Hospitals of Aarau, Bellinzona, Chur, Lugano, Luzern, Sion and St. Gallen.
Trial preparation started June 1st 2016. The first patient was enrolled at the Inselspital during the second week of March 2017. Trial end will be Mai 31st 2021.
More information can be found at www.nostone.ch