Randomized, double-blind, placebo-controlled crossover trial assessing the impact of the SGLT2 inhibitor empagliflozin on urinary supersaturations in kidney stone formers (SWEETSTONE)

Study identification

• EU PAS number:
  EUPAS43690
• Study ID:
  49154
• Official title and acronym:
  Randomized, double-blind, placebo-controlled crossover trial assessing the impact of the SGLT2 inhibitor empagliflozin on urinary supersaturations in kidney stone formers (SWEETSTONE)
• DARWIN EU® study:
  No
• Study countries:
  Switzerland
• Study description:
  Kidney stones are a global healthcare problem. Given the high recurrence rate, the morbidity related to symptomatic stone disease and the enormous healthcare expenditures and indirect cost associated with kidney stones, an effective medical prophylaxis is clearly an unmet need. Explanatory analyses of randomized controlled trials with sodium/glucose co-transporter isoform 2 (SGLT2) inhibitors indicated a 30-50% reduced rate of stone events in patients with diabetes, but the underlying mechanisms remain unclear. We aim to determine the effect of empagliflozin, the best-characterized SGLT2 inhibitor to date, on urinary supersaturations in non-diabetic kidney stone formers to evaluate their therapeutic potential for recurrence prevention.
• Study status:
  Finalised

Research institutions and networks

Institutions

Inselspital

Study timelines

Date when funding contract was signed

Actual:16/11/2020

Study start date

Actual:25/08/2021

Date of final study report

Planned:30/06/2023

Actual:28/04/2023

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim (Schweiz) GmbH, Inselspital Bern, Switzerland (intramural)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

ClinicalTrials.gov: NCT04911660
Kofam: SNCTP000004272

Publication study report