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

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT04911660
Phase
PHASE2
Status
Completed

Conditions

  • Kidney Stone

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 25 MG — DRUG
    1 empagliflozin 25 mg capsule per day for 14 days
  • Placebo — OTHER
    1 placebo capsule per day for 14 days

Study Details

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.

Key Dates

Start date
Aug 25, 2021
Status verified
May 2023
Primary completion
Mar 30, 2023
Completion
Apr 28, 2023

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Active Comparator: Empagliflozin + Placebo
    1 capsule containing 25 mg empagliflozin per day for 14 days, followed by a 14-42 days wash-out phase and a second treatment phase with 1 capsule containing placebo for 14 days.
  • Placebo Comparator: Placebo + Empagliflozin
    1 capsule containing placebo per day for 14 days, followed by a 14-42 days wash-out phase and a second treatment phase with 1 capsule containing 25 mg empagliflozin for 14 days.

Primary Outcome Measure

Primary outcome component 1 - calcium oxalate supersaturation in urine (empagliflozin treatment) [ Time Frame: Oxalate supersaturation will be determined at baseline and after 14 days treatment with empagliflozin ]

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