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Hydrochlorothiazide for Kidney Stone Recurrence Prevention

NCT03057431 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2024-02-01

Study results available
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Summary

The investigators plan to assess the efficacy of standard and low dose HCTZ treatment in the recurrence prevention of calcium-containing kidney stones. More specifically, the investigators aim to assess the dose-response relationship for three different dosages of HCTZ.

Study intervention: HCTZ 12.5 mg, 25 mg or 50 mg once daily per os for 24 or 36 months. In addition, all patients in HCTZ treatment arms will receive state-of-the-art non-pharmacologic recommendations for stone prevention according to current guidelines.

Control intervention: Placebo once daily per os for 24 to 36 months. In addition, all patients in the placebo arm will receive state-of-the-art non-pharmacologic recommendations for stone prevention according to current guidelines.

Conditions

  • Nephrolithiasis

Interventions

DRUG

Placebo oral capsule

Once daily for 3 years

DRUG

12.5 mg hydrochlorothiazide

Once daily for 3 years

DRUG

25.0 mg hydrochlorothiazide

Once daily for 3 years

DRUG

50.0 mg hydrochlorothiazide

Once daily for 3 years

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Daniel Fuster, Prof MD · Division of Nephrology and Hypertension, Bern University Hospital, Bern, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2021-12-03
Completion
2022-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03057431 on ClinicalTrials.gov