Hyperoxaluria, Urolithiasis
Conditions
Keywords
Urolithiasis, Hyperoxaluria
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.
Interventions
DRUGDapagliflozin
10mg Dapagliflozin daily for 8 weeks
DRUGHydrochlorothiazide
50mg Hydrochlorothiazide daily for 8 weeks
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Δ of urinary oxalate excretion | 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
| Measure | Time frame | Description |
|---|---|---|
| Δ of urinary calcium excretion | 8 weeks | 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. (Δ week0 and week 8 in mmol/L) |
| Change of serum kreatinine | 8 weeks | 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. |
| Frequency of urolithiasis | 12 months | Frequency of sympothomatic or treatment worthy urolithiasis events within the 12 month lasting afterward study period. (in events/ person/ year) |
| Tolerability of SGLT-2inhibitor therapy | 8 weeks | Tolerability of the SGLT-2 inhibitors within 8 weeks lasting therapy phase assessed by a physician in \[Type of adverse event; Start (date and time); End (date and time); Severity (mild, moderate, severe); Serious (no / yes); Unexpected (no / yes); Outcome (resolved, resolving, not resolved, resolved with sequelae, unknown, fatal); Relation to study drug (Related/ Probably/ Possibly/ Unlikely/ Not related/ Not assessable)\]. |
| Change of eGFR | 8 weeks | 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. |
Countries
Austria
Contacts
Primary ContactZeljko Kikic, Assoc.Prof.Priv.Doz.Dr
Outcome results
None listed