RecruitingPhase 2NCT06435858

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

Sponsor

Cantonal Hospital Graubuenden

Enrollment

40 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Autosomal Dominant Polycystic Kidney Disease

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

\- Patients 18-75 years old with ADPKD, defined according to international diagnostic and classification criteria14, treated at Cantonal Hospital Graubünden (KSGR) and the University Hospital Zürich (USZ) independent of baseline treatment with the vasopressin receptor antagonist Tolvaptan
Informed consent as documented by signature

Exclusion Criteria15

\- 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 requiring antibiotic 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 study period of participation in the trial:
Thiazide diuretics
Carbonic anhydrase inhibitors
Sodium bicarbonate
, 25 (OH) vitamin D (calcitriol)
Bisphosphonate, denosumab, teriparatide
Pregnant or lactating women
Known allergy to study drug
Inability to understand and follow the protocol