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Prevention study for Kidney Stone
Official title Indapamide and Chlorthalidone to Reduce Urine Supersaturation for Kidney Stone Prevention
ClinicalTrials.gov ID: NCT06111885
What this study is testing
What is Indapamide 2.5 MG?
Indapamide 2.5 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for kidney stone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Patients with secondary causes of recurrent calcium kidney stones including severe eating disorders (anorexia or bulimia), chronic bowel disease...
- Patients with the following medications: Thiazide or loop diuretics, carbonic anhydrase inhibitors (including topiramate), xanthine oxidase...
- 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...
- Patients with hepatic encephalopathy or severe liver insufficiency.
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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...
- Previous (within 3 months prior to randomization) or concomitant participation in another treatment clinical trial.
- Previous participation in INDAPACHLOR.
- Inability to understand and follow the protocol.
- Allergy to any one of the study drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.