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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Switzerland
Inselspital, Department of Nephrology and Hypertension
RECRUITING
Bern
Contact Information
Primary
Daniel G Fuster, M.D.
daniel.fuster@insel.ch
+41 (0)31 632 31 44
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 99
Treatments
Active_comparator: Indapamide + Hydrochlorothiazide + Chlorthalidone
1 capsule containing 2.5 mg indapamide per day for 28 days, followed by a 28 days wash out phase, followed by a second treatment phase with 1 capsule containing 50 mg hydrochlorothiazide per day for 28 days, followed by a 28 days wash out phase, followed by a third treatment phase with 1 capsule containing 25 mg chlorthalidone per day for 28 days.
Active_comparator: Hydrochlorothiazide + Chlorthalidone + Indapamide
1 capsule containing 50 mg hydrochlorothiazide per day for 28 days, followed by a 28 days wash out phase, followed by a second treatment phase with 1 capsule containing 25 mg chlorthalidone per day for 28 days, followed by a 28 days wash out phase, followed by a third treatment phase with 1 capsule containing 2.5 mg indapamide per day for 28 days.
Active_comparator: Chlorthalidone + Indapamide + Hydrochlorothiazide
1 capsule containing 25 mg chlorthalidone per day for 28 days, followed by a 28 days wash out phase, followed by a second treatment phase with 1 capsule containing 2.5 mg indapamide per day for 28 days, followed by a 28 days wash out phase, followed by a third treatment phase with 1 capsule containing 50 mg hydrochlorothiazide per day for 28 days.
Active_comparator: Hydrochlorothiazide + Indapamide + Chlorthalidone
1 capsule containing 50 mg hydrochlorothiazide per day for 28 days, followed by a 28 days wash out phase, followed by a second treatment phase with 1 capsule containing 2.5 mg indapamide per day for 28 days, followed by a 28 days wash out phase, followed by a third treatment phase with 1 capsule containing 25 mg chlorthalidone per day for 28 days.
Active_comparator: Indapamide + Chlorthalidone + Hydrochlorothiazide
1 capsule containing 2.5 mg indapamide per day for 28 days, followed by a 28 days wash out phase, followed by a second treatment phase with 1 capsule containing 25 mg chlorthalidone per day for 28 days, followed by a 28 days wash out phase, followed by a third treatment phase with 1 capsule containing 50 mg hydrochlorothiazide per day for 28 days.
Active_comparator: Chlorthalidone + Hydrochlorothiazide + Indapamide
1 capsule containing 25 mg chlorthalidone per day for 28 days, followed by a 28 days wash out phase, followed by a second treatment phase with 1 capsule containing 50 mg hydrochlorothiazide per day for 28 days, followed by a 28 days wash out phase, followed by a third treatment phase with 1 capsule containing 2.5 mg indapamide per day for 28 days.
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern
Collaborators: Department of clinical research, Bern