Using indapamide and chlorthalidone to prevent kidney stones
Randomized, Double-blind, Crossover Trial Assessing the Efficacy of Indapamide and Chlorthalidone Compared to Hydrochlorothiazide for the Reduction of Urine Supersaturation for Kidney Stone Prevention
This study is testing whether two long-lasting medications, indapamide and chlorthalidone, can help prevent kidney stones better than a shorter-acting medication called hydrochlorothiazide.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | denusomab |
| Locations | 1 site (Bern) |
| Trial ID | NCT06111885 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with a history of recurrent kidney stones containing calcium.
Not a fit: Patients with secondary causes of kidney stones or those currently taking certain medications that affect diuretic metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective pharmacological option for preventing recurrent kidney stones, improving patient quality of life.
How similar studies have performed: While thiazide diuretics have been used for kidney stone prevention, this study is novel as it compares long-acting thiazide-like diuretics directly, which has not been previously done.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bern
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.