Kidney Week

Abstract: SA-PO277

NOSTONE Trial: Randomized Double-Blind Placebo-Controlled Trial Assessing the Efficacy of Standard and Low-Dose Hydrochlorothiazide Treatment in the Recurrence Prevention of Calcareous Nephrolithiasis

Session Information

• Bone and Mineral Metabolism: Calcium, Magnesium, Kidney Stones
  November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Bone and Mineral Metabolism

• 402 Bone and Mineral Metabolism: Clinical

Authors

• Dhayat, Nasser, Department of Nephrology and Hypertension, Bern University Hospital, Bern, Switzerland

Nasser Dhayat,

• Bonny, Olivier, Service of Nephrology, Department of Medicine, Lausanne University Hospital, Lausanne, Switzerland

Olivier Bonny,

• Roth, Beat, Department of Urology, University of Bern, Bern, Switzerland

Beat Roth,

• Tamò, Luca, Clinical Trials Unit (CTU Bern), Medical Faculty, University of Bern, Bern, Switzerland

Luca Tamò,

• Fuster, Daniel G., Department of Nephrology and Hypertension, Bern University Hospital, Bern, Switzerland

Daniel G. Fuster,

Group or Team Name

• on behalf of the NOSTONE Investigators

Background

Nephrolithiasis is a global healthcare problem with a current lifetime risk of up to 18.8 % in men and 9.4 % in women. Without specific treatment, 5- and 20-year recurrence rates are 40 % and 75 %, respectively. 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.
Efficacy of thiazides for kidney stone prevention was tested in 11 trials in the past. However, all these trials had major methodological deficiencies. Nowadays, thiazides are widely used in the treatment of recurrent nephrolithiasis and arterial hypertension, but at significantly lower doses. In the case of recurrent nephrolithiasis, however, this practice is not supported by randomized evidence. Thus, evidence for benefits and harms of thiazides in the prevention of kidney stones remains unclear.

Methods

NOSTONE is a multicenter, randomized, placebo-controlled, double-blind, parallel-group trial with the purpose to assess the dose-response relationship for three different dosages of hydrochlorothiazide (placebo, 12.5mg, 25.0mg, 50.0mg) in kidney stone prevention. The primary outcome is the incidence of stone recurrence (a composite of symptomatic or radiologic recurrence) at 3 years, a low-dose CT will be performed at the beginning and the end of the trial. A total of 416 patients from 12 hospitals throughout Switzerland will be included in the study.

Results

NOSTONE received all necessary approvals by the end of February 2017. Recruitment started in Bern on the 9^th of March 2017, all study sites are operative since June 30^th 2017. As of May 30^th 2019, 270 patients were randomized in the trial (regular updates: www.nostone.ch). The end of recruitment is foreseen for August 2019. Baseline data concerning the study population will be available after the end of recruitment.

Conclusion

The NOSTONE study will provide critical information to physicians for the treatment of kidney stones. The impact of the results of this study will affect many patients currently treated with hydrochlorothiazide for the prevention of recurrent nephrolithiasis.

Funding

• Government Support - Non-U.S.