---
title: Dapagliflozin and Hydrochlorothiazide in Recurring Kidney Stone Patients
nct_id: NCT05443932
overall_status: UNKNOWN
phase: PHASE4
sponsor: Medical University of Vienna
study_type: INTERVENTIONAL
primary_condition: Urolithiasis
countries: Austria
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05443932.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05443932"
ct_last_update_post_date: 2023-10-23
last_seen_at: "2026-05-12T07:24:51.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Dapagliflozin and Hydrochlorothiazide in Recurring Kidney Stone Patients

**Official Title:** Dapagliflozin and Hydrochlorothiazide Treatment in Recurring Kidney Stone Patients - a Randomised Single Center Cross-over Study

**NCT ID:** [NCT05443932](https://clinicaltrials.gov/study/NCT05443932)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 32
- **Lead Sponsor:** Medical University of Vienna
- **Conditions:** Urolithiasis, Hyperoxaluria
- **Start Date:** 2024-03-04
- **Completion Date:** 2025-12-31
- **CT.gov Last Update:** 2023-10-23

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Washout Phase and treatment arms** (OTHER) — 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).

## Interventions

- **Dapagliflozin** (DRUG) — 10mg Dapagliflozin daily for 8 weeks
- **Hydrochlorothiazide** (DRUG) — 50mg Hydrochlorothiazide daily for 8 weeks

## Primary Outcomes

- **Δ of urinary oxalate excretion** _(time frame: 8 weeks)_ — As the primary endpoint the investigators defined the change of the urine oxalate excretion assessed by 24 h hour urine by 25% after 8 weeks of SGLT-2 inhibitor therapy compared to the baseline value that was collected in the washout phase before the treatment period. (Δ week0 and week 8 in mmol/L)

## Secondary Outcomes

- **Δ of urinary calcium excretion** _(time frame: 8 weeks)_
- **Change of serum kreatinine** _(time frame: 8 weeks)_
- **Frequency of urolithiasis** _(time frame: 12 months)_
- **Tolerability of SGLT-2inhibitor therapy** _(time frame: 8 weeks)_
- **Change of eGFR** _(time frame: 8 weeks)_

## Locations (1)

- Medical University of Vienna, Vienna, Austria

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.medical university of vienna|vienna||austria` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05443932.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05443932*  
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