Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease

Last updated: September 8, 2025
Sponsor: Cantonal Hospital Graubuenden
Overall Status: Active - Recruiting

Phase

2

Condition

Kidney Failure

Treatment

Placebo

Empagliflozin

Clinical Study ID

NCT06435858
2024-00070
  • Ages 18-75
  • All Genders

Study Summary

This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.

Patients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. The primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. Secondary outcomes include diuresis, safety and tolerability.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    • Patients 18-75 years old with ADPKD, defined according to international diagnosticand classification criteria14, treated at Cantonal Hospital Graubünden (KSGR) andthe University Hospital Zürich (USZ) independent of baseline treatment with thevasopressin receptor antagonist Tolvaptan

  • Informed consent as documented by signature

Exclusion

Exclusion Criteria:

    • renal replacement therapy or kidney allograft recipient

  • chronic kidney disease CKD KDIGO Stage G4 (eGFR under 30ml/min/1.73m2)

  • patients younger 18 years of age

  • Diabetes mellitus type 1

  • recurrent urinary tract infections (UTI) defined as more than 3 infections requiringantibiotic treatment or over 1 requiring hospitalization/year.

  • Patients with uncontrolled hypertension (defined as ambulatory systolic BP over 180mmHg), liver cirrhosis (Child Pugh B and C)

  • Patients not able or not willing to stop the following medications during the studyperiod of participation in the trial:

  • Thiazide diuretics

  • Carbonic anhydrase inhibitors

  • Sodium bicarbonate

  • 1, 25 (OH) vitamin D (calcitriol)

  • Bisphosphonate, denosumab, teriparatide

  • Pregnant or lactating women

  • Known allergy to study drug

  • Inability to understand and follow the protocol

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 01, 2024
Estimated Completion Date:
October 31, 2025

Study Description

This investigator-initiated randomised, single-blind, placebo-controlled cross-over study aims to better understand tubular electrolyte handling of divalent ions in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.

After randomization, at week 0, participants collect 24-hour urine sample and a patient visit to assess vitals and blood tests takes place. After this visit, period 1 starts with a 2-week treatment of either Empagliflozin 10mg or Placebo.

At week 2, the second 24-hour-urine sample and 2. patient visit and blood test take place. After this visit, wash-out period for 2 weeks starts where no study drug will be administered At week 4, the period 2, the crossover-period starts for an additional 2 weeks. At week 6; a final and third 24-hour urine sample, clinical visit and blood test takes place.

At week 3 & 7, a phone consultation will assess safety.

Connect with a study center

  • University Hospital Zurich, Division of Nephrology

    Zurich 2657896, Canton of Zurich 2657895 8091
    Switzerland

    Active - Recruiting

  • Cantonal Hospital Graubuenden

    Chur, Graubuenden 7000
    Switzerland

    Site Not Available

  • Cantonal Hospital Graubuenden

    Chur 2661169, Kanton Graubünden 2660522 7000
    Switzerland

    Active - Recruiting

  • University Hospital Zurich, Division of Nephrology

    Zürich, Zurich 8091
    Switzerland

    Site Not Available

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