Interventions for preventing the progression of autosomal dominant polycystic kidney disease.
Kitty St Pierre, Brydee A Cashmore, Davide Bolignano...
https://pubmed.ncbi.nlm.nih.gov/39356039/Actively Recruiting
Led by Cantonal Hospital Graubuenden · Updated on 2025-09-12
40
Participants Needed
2
Research Sites
13 weeks
Total Duration
Researchers are investigating how the SGLT2 inhibitor Empagliflozin affects the handling of important minerals like calcium, phosphate, and magnesium in patients with autosomal dominant polycystic kidney disease ADPKD. This phase 2, randomized, single-blind, placebo-controlled crossover study aims to improve understanding of kidney function related to these minerals in this patient group. Participants will be randomly assigned to receive either Empagliflozin 10mg or a placebo for two weeks. This is followed by a two-week wash-out period without treatment. After the wash-out, participants will switch to the other treatment for another two weeks. Throughout the study, urine and blood samples will be collected to monitor the effects. During the study, participants will provide 24-hour urine samples and attend clinical visits for vital signs and blood tests at multiple time points. Phone consultations will be conducted to assess safety. The main measure is how the kidneys handle calcium, phosphate, and magnesium after two weeks of treatment, with additional measurements including urine output, safety, and tolerability. The total study duration spans about six weeks per participant.
CONDITIONS
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
P
Patrick Hofmann, MD
T
Thomas Fehr, MD
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Cantonal Hospital Graubuenden
Lead Sponsor
University of Zurich
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 8 weeks
Participants receive either Empagliflozin 10mg or placebo for 2 weeks, followed by a 2-week wash-out period, then crossover to the alternate treatment for another 2 weeks. During treatment periods, participants provide urine samples, undergo clinical visits, and have blood tests.
3 clinical visits (in-person) and 2 phone consultations
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Kitty St Pierre, Brydee A Cashmore, Davide Bolignano...
https://pubmed.ncbi.nlm.nih.gov/39356039/Cantonal Hospital Graubuenden
Lead Sponsor
University of Zurich
Collaborating Sponsor