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

Sponsor
Cantonal Hospital Graubuenden
Study ID
NCT06435858
Phase
PHASE2
Status
Completed

Conditions

  • Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin 10mg
  • Placebo — DRUG
    Placebo capsule

Study Details

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.

Key Dates

First listed
May 30, 2024
Start date
Sep 1, 2024
Status verified
Sep 2026
Primary completion
Jul 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    Empagliflozin 10mg
  • Placebo Comparator: Control
    Placebo

Primary Outcome Measure

24-hour Urinary Phosphate [ Time Frame: End of each 14 day treatment period ]

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