Dapagliflozin and Hydrochlorothiazide in Recurring Kidney Stone Patients

Sponsor
Medical University of Vienna
Study ID
NCT05443932
Phase
PHASE4
Status
Unknown

Conditions

  • Hyperoxaluria
  • Urolithiasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    10mg Dapagliflozin daily for 8 weeks
  • Hydrochlorothiazide — DRUG
    50mg Hydrochlorothiazide daily for 8 weeks

Study Details

Current prevention strategies in patients with recurrence of kidney stones show especially in high-risk patients a diversely and in the long-term not successful outcome in a sustainable number of cases. Recent studies have revealed that Dapagliflozin has the potential to decrease risk and incidence of urolithiasis events especially in patients suffering from Diabetes. The investigators propose that Dapagliflozin has the potential to increase the metabolic situation of hyperoxaluric patients with recurrence of urolithiasis. The investigators therefore test whether Dapagliflozin can decrease the oxalate excretion compared to the current strategy with Hydrochlorothiazide. The study may open up a new way of preventing urolithiasis in patients with high-risk of recurring urolithiasis.

Key Dates

Start date
Mar 4, 2024
Status verified
Oct 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • 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).

Primary Outcome Measure

Δ of urinary oxalate excretion [ Time Frame: 8 weeks ]

Central Contacts

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