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Prevention study for Kidney Stone
Official title Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
ClinicalTrials.gov ID: NCT06653738
What this study is testing
What is Empagliflozin 10 MG?
Empagliflozin 10 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for kidney stone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this randomized trial with a 2-by-2 factorial design is to test the efficacy 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.
- Phase 3: a large, late-stage study
- Time commitment: about 10 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written, informed consent.
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- Written, informed consent.
- 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...
- 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
- Treatment with an SGLT2i within 4 weeks prior to randomization.
- Active cancer treatment
- Pregnancy and/or breastfeeding. Women of childbearing potential (i.e., premenopausal women who have not undergone surgical sterilization and are sexually active with a male partner) must have a negative urine or blood...
- Known allergy to the study drug
- Inability to understand and follow the study procedures
- Vulnerable individual, e.g. individual incapable of judgement or currently incarcerated or otherwise institutionalized (priosner), or refugee
- Concomitant participation in another treatment clinical trial within 4 weeks prior to randomization and during the current trial
- Prior enrollment in the EMPASTONE trial
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Paris, France
- Berlin, Germany
- Naples, Italy
- Verona, Italy
- Aarau, Switzerland
- Baden, Switzerland
- Basel, Switzerland
- Bern, Switzerland
- Chur, Switzerland
- Fribourg, Switzerland
- Geneva, Switzerland
- Lausanne, Switzerland
- Lucerne, Switzerland
- Lugano, Switzerland
- Neuchâtel, Switzerland
- Olten, Switzerland
- Sankt Gallen, Switzerland
- Sion, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Paris, France; Berlin, Germany; Naples, Italy; Verona, Italy; Aarau, Switzerland and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.