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

NCT06653738 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: EMPASTONE Trial
• Study Type: interventional
• Target: 380
• Locations: 4 countries
• Sites: 21

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of patients with radiologic stone recurrence

  Radiological stone recurrence is defined as a new stone formed or enlargement of a preexisting stone (assessed by low-dose CT of the kidney at the end of the study compared to the low-dose CT of the kidney at the baseline visit).

  After 3 years

Secondary Outcomes (2)

• Time to symptomatic kidney stone recurrence up to 3 years (time-to-event)

  From enrollment to the end of treatment at 3 years

• Number of symptomatic stone recurrences per patient (cumulative)

  From enrollment to the end of treatment at 3 years

Other Outcomes (9)

• Changes in blood parameters

  From enrollment to the end of treatment at 3 years

• Changes in urine parameters

  From enrollment to the end of treatment at 3 years

• Changes in blood pressure

  From enrollment to the end of treatment at 3 years

Study Arms (4)

Empagliflozin and personalized dietary counseling

EXPERIMENTAL

Empagliflozin 25 mg once daily per os and personalized dietary counseling for 3 years

Drug: Empagliflozin 25 MG; Behavioral: Personalized dietary counseling

Placebo and personalized dietary counseling

PLACEBO COMPARATOR

Placebo once daily per os and personalized dietary counseling for 3 years

Drug: Placebo; Behavioral: Personalized dietary counseling

Empagliflozin and generic dietary counseling

EXPERIMENTAL

Empagliflozin 25 mg once daily per os and generic dietary counseling for 3 years

Drug: Empagliflozin 25 MG; Behavioral: Generic dietary counseling

Placebo and generic dietary counseling

PLACEBO COMPARATOR

Placebo once daily per os and generic dietary counseling for 3 years

Drug: Placebo; Behavioral: Generic dietary counseling

Interventions

Empagliflozin 25 MG DRUG

Once daily per os for 3 years

Empagliflozin and generic dietary counseling; Empagliflozin and personalized dietary counseling

Placebo DRUG

Once daily per os for 3 years

Placebo and generic dietary counseling; Placebo and personalized dietary counseling

Personalized dietary counseling BEHAVIORAL

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

Empagliflozin and personalized dietary counseling; Placebo and personalized dietary counseling

Generic dietary counseling BEHAVIORAL

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

Empagliflozin and generic dietary counseling; Placebo and generic dietary counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written, informed consent.
• Age 18 years or older.
• Recurrent kidney stone disease (2 or more stone episodes in the last 10 years).
• 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.

You may not qualify if:

• Patients with a known history of secondary or Mendelian causes of calcium nephrolithiasis
• Type I diabetes mellitus
• History of ketoacidosis
• Treatment with SGLT2 Inhibitor
• CKD (defined as CKD-EPI eGFR \<30 mL/min)
• Kidney transplant recipient
• History of recurrent urinary tract infections (\>3 episodes/year)
• Active cancer treatment
• Less than 3-year life expectancy
• Pregnancy and breastfeeding
• Inability to understand and follow the study protocol
• Known allergy to the study drug
• Concomitant participation in another interventional clinical trial

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (21)

University Hospital Amiens-Picardie

Amiens, 80054, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Charité University Medicine Berlin

Berlin, 10117, Germany

Location

Verona University Hospital

Verona, 37134, Italy

Location

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

Regionalspital Bellinzona e Valli

Bellinzona, 6500, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Kantonsspital Chur

Chur, 7000, Switzerland

Location

Kantonsspital Fribourg

Fribourg, 1708, Switzerland

Location

University Hospital Geneva (HUG)

Geneva, 1211, Switzerland

Location

Lausanne University Hospital (CHUV)

Lausanne, 1011, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6016, Switzerland

Location

Regionalspital Lugano

Lugano, 6900, Switzerland

Location

Kantonsspital Neuchâtel

Neuchâtel, 2000, Switzerland

Location

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Kantonsspital Sion

Sion, 1950, Switzerland

Location

Kantonsspital Solothurn

Solothurn, 4500, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Schietzel S, Bally L, Cereghetti G, Faller N, Moor MB, Vogt B, Rintelen F, Trelle S, Fuster D. Impact of the SGLT2 inhibitor empagliflozin on urinary supersaturations in kidney stone formers (SWEETSTONE trial): protocol for a randomised, double-blind, placebo-controlled cross-over trial. BMJ Open. 2022 Mar 14;12(3):e059073. doi: 10.1136/bmjopen-2021-059073.

  PMID: 35288397 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Fuster

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel G Fuster, Prof MD

CONTACT

+41 31 632 31 44; daniel.fuster@unibe.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be allocated to either empagliflozin 25 or placebo once daily, and to either personalized or generic dietary counseling (2x2 factorial design).

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); IT (1); CH (17); DE (1)