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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05443932
Other study ID # Urolithiasis
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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