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Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention

NCT06653738 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2024-10-22

No results posted yet for this study

Summary

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 25 mg once daily per os for 36 months
* Personalized dietary counseling for 36 months.

Control interventions:

* Placebo once daily per os for 36 months
* Generic dietary counseling for 36 months.

Conditions

  • Kidney Stone
  • Nephrolithiasis
  • Dietary Exposure

Interventions

DRUG

Empagliflozin 25 MG

Once daily per os for 3 years

DRUG

Placebo

Once daily per os for 3 years

BEHAVIORAL

Personalized dietary counseling

Personalized dietary counseling based on repeat 24-hr urine collections and dietary assessments for 3 years

BEHAVIORAL

Generic dietary counseling

Generic dietary counseling based on current guidelines without 24-hr urine collection results and without specific dietary assessments for 3 years

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Daniel Fuster · Inselspital, Bern University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2030-02-28
Completion
2030-06-30

Countries

  • France
  • Germany
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06653738 on ClinicalTrials.gov