Impact of the SGLT2 Inhibitor Empagliflozin on Urinary Supersaturations in Kidney Stone Formers

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to test the effect of a new drug on the composition of the urine in kidney stone patients. This new drug (Jardiance®, substance: empagliflozin) is currently approved in Switzerland for the treatment of patients with diabetes. Data from previous studies with and without diabetes suggest that it may have a beneficial effect on the composition of the urine and thereby reduce the risk of developing kidney stones.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Boehringer Ingelheim; University of Bern
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Informed Consent as documented by signature

• Age between 18 and 74 years old

• One or more kidney stone event(s) in the past

• Any past kidney stone containing ≥ 80 % of calcium or ≥ 80 % of uric acid

• HbA1c < 6.5 %

Exclusion Criteria:

• Patients with secondary causes of recurrent nephrolithiasis:

• Severe eating disorders (anorexia or bulimia)

• Chronic bowel disease, past intestinal or bariatric surgery

• Sarcoidosis

• Primary hyperparathyroidism

• Complete distal tubular acidosis

• Patients with the following medications:

• Anti-diabetic treatment (insulin and non-insulin agents)

• Patients not able or not willing to stop the following medication during the period of participation in the trial (including a time window of 4 weeks wash out prior to randomization):

• Diuretics (thiazide and loop diuretics)

• Carbonic anhydrase inhibitors (including topiramate)

• Xanthine oxidase inhibitors

• Alkali, including potassium citrate or sodium bicarbonate

• Treatment with 1,25-OH Vitamin D (calcitriol)

• Calcium supplementation

• Bisphosphonates, Denosumab, Teriparatide

• Glucocorticoids

• Obstructive uropathy, if not treated successfully

• Genito-urinary infection, if not treated successfully

• Chronic kidney disease (defined as CKD-EPI eGFR < 60 mL/min per 1.73 m2 body surface area)

• Kidney transplant

• Pregnant and lactating women [urine pregnancy test to be performed for women of childbearing potential (defined as women who are not surgically sterilized/ hysterectomized, and/ or who are postmenopausal for less than 12 months)] or women of childbearing potential that refuse to use an effective contraceptive method (birth control pill or IUD).

• Inability to understand and follow the protocol

• Known allergy to the study drug

• Participation in another interventional clinical trial within 4 weeks prior to baseline and during the current trial