Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06111885

Indapamide and Chlorthalidone to Reduce Urine Supersaturation for Kidney Stone Prevention

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-06

99

Participants Needed

1

Research Sites

143 weeks

Total Duration

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AI-Summary

What this Trial Is About

The aim of this study is to test the efficacy of the two long-acting thiazide-like diuretics indapamide and chlorthalidone in reducing urine supersaturation for calcium oxalate and calcium phosphate compared to the short-acting thiazide diuretic hydrochlorothiazide for the prevention of calcium-containing kidney stones.

CONDITIONS

Official Title

Indapamide and Chlorthalidone to Reduce Urine Supersaturation for Kidney Stone Prevention

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written, informed consent.
  • Age 18 years or older.
  • Recurrent kidney stone disease (2 or more kidney stone episodes in the last 10 years prior to randomisation).
  • Past kidney stone containing 50% or more calcium oxalate, calcium phosphate, or a mixture of both.
Not Eligible

You will not qualify if you...

  • Secondary causes of recurrent calcium kidney stones such as severe eating disorders, chronic bowel disease, intestinal or bariatric surgery, sarcoidosis, primary hyperparathyroidism, or chronic urinary tract infection.
  • Current use of thiazide or loop diuretics, carbonic anhydrase inhibitors (including topiramate), xanthine oxidase inhibitors, alkali, active vitamin D, calcium supplements, bisphosphonates, denusomab, teriparatide, SGLT2 inhibitors, strong CYP3A4 inhibitors or inducers, or lithium unless willing to stop these 28 days before randomization.
  • Chronic kidney disease with estimated glomerular filtration rate below 30 mL/min.
  • Glomerulonephritis.
  • Severe biochemical imbalances including severe hypercalcemia, therapy-resistant hypokalemia, severe hyponatremia, or symptomatic hyperuricemia.
  • Hepatic encephalopathy or severe liver failure.
  • Severe heart failure.
  • Recent cerebrovascular event.
  • Solid organ transplant.
  • Pregnant or breastfeeding women (with urine pregnancy test for women of childbearing potential).
  • Participation in another interventional clinical trial within 3 months prior to randomization.
  • Previous participation in this study.
  • Inability to understand or follow the study protocol.
  • Allergy to any of the study drugs.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Inselspital, Department of Nephrology and Hypertension

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

D

Daniel G Fuster, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

6

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