Dapagliflozin and Hydrochlorothiazide in Recurring Kidney Stone Patients
Urolithiasis, Hyperoxaluria
About this trial
This is an interventional prevention trial for Urolithiasis focused on measuring Urolithiasis, Hyperoxaluria
Eligibility Criteria
Inclusion Criteria:
• Calcium-oxalate stone formers with high risk of reoccurrence defined as:
- At least two symptomatic or surgically treated kidney stones within the last 10 years and/or
- Single stone kidney formers with risk factors including: a.) Positive medical family history on kidney stone formations of at least one blood related relative in the first degree or at least two blood related relatives in the second degree and/ or b.) Onset of kidney stone formations within the third life decade or earlier and/ or c.) Metabolic syndrome d.) Obesity (BMI ≥ 30 kg/m²)
Exclusion Criteria:
- Age < 18 years
- Malabsorption disorder
- eGFR < 30 ml/min/1,73 m2
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Other
Washout Phase and treatment arms
At first there will be wash-out phase I with daily placebo administration for all participants. All patients will receive blood- and 24h-urine screenings in week 0 and 6 to get baseline data and also a low-dose native CT of the urinary tract in week 6. In preparation of the HCT phase all participants will daily receive an oral placebo. In week 7 the HCT phase will start and all patients will receive an oral therapy with 50mg of HCT daily; the treatment response will be evaluated by blood- and urine test after 4 weeks of therapy (week 10). After that, in washout phase II, the same test as before will be performed in week 0 and 6 (weeks 15 and 20). At the end another therapy phase with an oral administration of 10mg dapagliflozin daily will be performed; the treatment response will be evaluated by blood- and urine test after 4 weeks of therapy (week 25). Finally, the same tests as before will be performed in wash-out phase III in week 0 and 6 (weeks 29 and 34).