Dapagliflozin and Hydrochlorothiazide in Recurring Kidney Stone Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Urolithiasis Hyperoxaluria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

There won´t be comparator arms in our study. Instead, the investigators plan to do blood- and 24h-urine screenings including oxalate and citrate as well as metabolomics tests out of blood and urine samples at crucial points of time of the study to get baseline and therapeutic data of the participants.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Dapagliflozin

Intervention Type DRUG

10mg Dapagliflozin daily for 8 weeks

Hydrochlorothiazide

Intervention Type DRUG

50mg Hydrochlorothiazide daily for 8 weeks

Interventions

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Dapagliflozin

10mg Dapagliflozin daily for 8 weeks

Intervention Type DRUG

Hydrochlorothiazide

50mg Hydrochlorothiazide daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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)