Indapamide and Chlorthalidone to Reduce Urine Supersaturation for Kidney Stone Prevention

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two medications, indapamide and chlorthalidone, to see if they can help prevent kidney stones by reducing certain substances in urine that can lead to stone formation. These medications are long-acting diuretics, which are drugs that help the body get rid of extra fluid. The study will compare their effectiveness against a shorter-acting diuretic called hydrochlorothiazide, which is already known to help some patients with kidney stones.

To participate in this trial, you need to be at least 18 years old and have had kidney stones two or more times in the past 10 years, with your stones containing mostly calcium. However, there are some people who cannot join, such as those with certain health conditions, those taking specific medications, or those who are pregnant or breastfeeding. If eligible, participants will receive treatment and regular check-ups to monitor their health and see how well the medications work in preventing kidney stones. This study is currently looking for participants, so it's a great opportunity for those who struggle with kidney stones to potentially find a new way to manage their condition.

Gender

ALL

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.