Indapamide and Chlorthalidone to Reduce Urine Supersaturation for Kidney Stone Prevention

• Status: Not yet recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborator: University of Bern
• Treatments: Chlorthalidone; Hydrochlorothiazide; Indapamide

Criteria

Inclusion Criteria:

• Written, informed consent.

• Age 18 years or older.

• Recurrent kidney stone disease (2 or more stone episodes in the last 10 years).

• Past kidney stone containing 50% or more of calcium oxalate, calcium phosphate 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, denosumab, teriparatide, sodium-glucose co-transporter 2 (SGLT2) inhibitors, strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers (may affect indapamide metabolism)

• Patients with chronic kidney disease, defined as estimated GFR (eGFR) according to CKD-EPI formula < 30ml/min).

• Patients with a kidney transplant

• Pregnant and lactating women.

• Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial.

• Inability to understand and follow the protocol.

• Allergy to study drugs.