Status:
COMPLETED
Impact of the SGLT2 Inhibitor Empagliflozin on Urinary Supersaturations in Kidney Stone Formers
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Boehringer Ingelheim
University of Bern
Conditions:
Kidney Stone
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief 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 Switze...
Detailed Description
Kidney stones - a global epidemic associated with obesity and diabetes Kidney stones are a worldwide healthcare problem with a current lifetime risk of \~18.8 % in men and \~9.4 % in women in Western...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04911660
Start Date
August 25 2021
End Date
April 28 2023
Last Update
May 12 2023
Active Locations (1)
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1
Inselspital, Department of Nephrology and Hypertension
Bern, Switzerland, 3010