Dapagliflozin and Hydrochlorothiazide in Recurring Kidney Stone Patients

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05443932
• Other study ID #: Urolithiasis
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 4, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Medical University of Vienna
• Contact: Zeljko Kikic, Assoc.Prof.Priv.Doz.Dr
• Phone: 0043 (0)1 40400 43910
• Email: zeljko.kikic[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperoxaluria
• Kidney Calculi
• Urinary Calculi
• Urolithiasis

Intervention

Drug:
• Dapagliflozin
10mg Dapagliflozin daily for 8 weeks
• Hydrochlorothiazide
50mg Hydrochlorothiazide daily for 8 weeks

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	? of urinary oxalate excretion	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. (? week0 and week 8 in mmol/L)	8 weeks
Secondary	? of urinary calcium excretion	Reduction of the urine calcium 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. (? week0 and week 8 in mmol/L)	8 weeks
Secondary	Change of serum kreatinine	Change of serum kreatinine (in mg/dL) assessed by blood collection after 8 weeks of SGLT-2 inhibitor therapy compared to the baseline value that was collected in the washout phase before the treatment period.	8 weeks
Secondary	Frequency of urolithiasis	Frequency of sympothomatic or treatment worthy urolithiasis events within the 12 month lasting afterward study period. (in events/ person/ year)	12 months
Secondary	Tolerability of SGLT-2inhibitor therapy	Tolerability of the SGLT-2 inhibitors within 8 weeks lasting therapy phase assessed by a physician in [Type of adverse event; Start (date and time); End (date and time); Severity (mild, moderate, severe); Serious (no / yes); Unexpected (no / yes); Outcome (resolved, resolving, not resolved, resolved with sequelae, unknown, fatal); Relation to study drug (Related/ Probably/ Possibly/ Unlikely/ Not related/ Not assessable)].	8 weeks
Secondary	Change of eGFR	Change of eGFR (in ml/min/1,73 m2) that was calculated from serum kreatinine that was assessed by blood collection after 8 weeks of SGLT-2 inhibitor therapy compared to the baseline value that was collected in the washout phase before the treatment period.	8 weeks