Using indapamide and chlorthalidone to prevent kidney stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of two long-acting thiazide-like diuretics, indapamide and chlorthalidone, in reducing urine supersaturation of calcium oxalate and calcium phosphate compared to the short-acting thiazide diuretic hydrochlorothiazide. It will be conducted as a single-center, prospective, randomized, double-blind, crossover trial. The goal is to determine if these medications can better prevent the recurrence of calcium-containing kidney stones, addressing a significant gap in current treatment options.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Written, informed consent.
* Age 18 years or older.
* Recurrent kidney stone disease (≥2 kidney stone episodes in the last 10 years prior to randomisation).
* Past kidney stone containing ≥50 % CaOx, CaP, or a mixture of both.

Exclusion criteria:

* Patients with secondary causes of recurrent calcium kidney stones including severe eating disorders (anorexia or bulimia), chronic bowel disease, intestinal or bariatric surgery, sarcoidosis, primary hyperparathyroidism, chronic urinary tract infection.
* Patients with the following medications: Thiazide or loop diuretics, carbonic anhydrase inhibitors (including topiramate), xanthine oxidase inhibitors, alkali, active vitamin D (calcitriol or similar), calcium supplementation, bisphosphonates, denusomab, teriparatide, sodium-glucose co-transporter 2 (SGLT2) inhibitors, strong CYP3A4 inhibitors or inducers (may affect indapamide metabolism), lithium (To be eligible for study participation, patients taking any of the above listed medications at screening must be willing to discontinue these medications at least 28 days before randomization).
* Patients with chronic kidney disease (defined as CKD-EPI eGFR \<30 mL/min).
* Patients with glomerulonephritis.
* Patients with the following biochemical imbalances: severe hypercalcemia (\>2.8 mmol/L), therapy-resistant hypokalemia or conditions with increased potassium loss, severe hyponatremia (\<130 mmol/L), symptomatic hyperuricemia.
* Patients with hepatic encephalopathy or severe liver insufficiency.
* Patients with severe cardiac insufficiency.
* Patient with a recent cerebrovascular event.
* Patients with a solid organ transplant.
* Pregnant and lactating women (A urine pregnancy test must be performed for women of child-bearing potential, defined as women who are not surgically sterilized/hysterectomized, and/or who are postmenopausal for less than 12 months).
* Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial.
* Previous participation in INDAPACHLOR.
* Inability to understand and follow the protocol.
* Allergy to any one of the study drugs.

Where it's running

• Inselspital, Department of Nephrology and Hypertension
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Daniel G Fuster, M.D. — Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, Bern Switzerland
• Study coordinator: Daniel G Fuster, M.D.
• Email: daniel.fuster@insel.ch
• Phone: +41 (0)31 632 31 44

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.