NCT06111885 Indapamide and Chlorthalidone to Reduce Urine Supersaturation for Kidney Stone Prevention
| NCT ID | NCT06111885 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Kidney Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 99 participants in total. It began in 2024-10-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Daniel G Fuster, M.D.
PRINCIPAL INVESTIGATOR
Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, Bern Switzerland
Frequently Asked Questions
Who can join the NCT06111885 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06111885 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06111885 currently recruiting?
Yes, NCT06111885 is actively recruiting participants. Contact the research team at daniel.fuster@insel.ch for enrollment information.
Where is the NCT06111885 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06111885 clinical trial?
NCT06111885 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Daniel G Fuster, M.D. at Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, Bern Switzerland. The trial plans to enroll 99 participants.
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