Phase 3: testing Empagliflozin 10 MG for Kidney Stone
The aim of this randomly assigned trial with a 2-by-2 factorial design is to test the how well it works of the SGLT2 inhibitor empagliflozin and personalized dietary counseling based on 24-hr urine collection results and dietary assessments for kidney stone recurrence prevention in patients with calcium kidney stones. Study interventions: * Empagliflozin 10 mg once daily per os for 36 months * Personalized dietary counseling for 36 months.
Official registry: https://clinicaltrials.gov/study/NCT06653738 · Insel Gruppe AG, University Hospital Bern · enrollment listed as 400
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Empagliflozin 10 MG, Placebo, or Personalized dietary counseling. The registry lists allocation as randomized. The aim of this randomly assigned trial with a 2-by-2 factorial design is to test the how well it works of the SGLT2 inhibitor empagliflozin and personalized dietary counseling based on 24-hr urine collection results and dietary assessments for kidney stone recurrence prevention in patients with calcium kidney stones.
They plan to enroll about 400 people at 21 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Randomized Placebo-controlled Trial to Assess Efficacies of EMPAgliflozin and Personalized Dietary Counselling for Kidney STONE Prevention in Patients With Calcium Kidney Stones Acronym: EMPASTONE Trial
Interventions: Empagliflozin 10 MG, Placebo, Personalized dietary counseling, Generic dietary counseling
Primary outcome (registry wording): Number of patients with radiologic stone recurrence
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Age 18 years or older
- Recurrent kidney stone disease with 2 or more stone episodes in the last 10 years prior to randomization
- Last kidney stone containing 50% or more of CaOx, CaP or a mixture of both
- If taking guideline-recommended medications for kidney stone prophylaxis (e.g. citrate salts), patients must have been on a stable regimen for at least 60 days before randomization and willing to remain on this stable regimen for the duration of the study
Who the registry excludes
- Known history of secondary or Mendelian causes of calcium nephrolithiasis
- Type I diabetes mellitus
- History of ketoacidosis
- Chronic Kidney Disease (CKD) stage 4 or 5 (defined as CKD-EPI eGFR \<30 mL/min)
- Kidney transplant recipient
- History of recurrent urinary tract infections, defined as \>3 episodes within the year prior to randomization
- Heart failure. Symptomatic patients with suspected heart failure must be evaluated before study enrollment
Public study contact (from the registry)
Daniel G Fuster, Prof MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
21 listed- University Hospital Amiens-Picardie — Amiens, France (not_yet_recruiting)
- Hôpital Tenon — Paris, France (not_yet_recruiting)
- Hôpital Européen Georges Pompidou — Paris, France (not_yet_recruiting)
- Charité University Medicine Berlin — Berlin, Germany (not_yet_recruiting)
- Università della Campania "Luigi Vanvitelli" — Naples, Italy (not_yet_recruiting)
- Verona University Hospital — Verona, Italy (not_yet_recruiting)
- Kantonsspital Aarau — Aarau, Switzerland (recruiting)
- Kantonsspital Baden — Baden, Switzerland (recruiting)
- University Hospital Basel — Basel, Switzerland (recruiting)
- Inselspital Bern — Bern, Switzerland (recruiting)
- Kantonsspital Chur — Chur, Switzerland (recruiting)
- Kantonsspital Fribourg — Fribourg, Switzerland (not_yet_recruiting)
FAQ about this NCT record
Is NCT06653738 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06653738?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06653738?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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