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Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease
Sponsor: University of Colorado, Denver
Summary
The investigator proposes a pilot randomized clinical trial to determine the safety and tolerability of empagliflozin in ADPKD patients. To achieve this, the investigator will conduct a 12-month parallel-group, randomized, double-blind, placebo-controlled trial in 50 ADPKD patients with an eGFR 30-90 mL/min/1.73m2.
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-11-18
Completion Date
2026-03-31
Last Updated
2025-05-13
Healthy Volunteers
No
Conditions
Interventions
Empagliflozin
Empagliflozin: The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-\[4-chloro-3-\[\[4-\[\[(3S)-tetrahydro-3furanyl\]oxy\]phenyl\]methyl\]phenyl\]-, (1S). Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile; soluble in 50% acetonitrile/water; and practically insoluble in toluene. Empagliflozin power will be added in white and bovine origin gelatin capsules. Each capsule of empagliflozin will contain 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: microcrystalline cellulose magnesium, stearate, dicalcium phosphate, and silicone dioxide.
Placebo
Placebo capsules will be matched in size and color to empagliflozin capsules. Each placebo capsule will contain the following inactive ingredients: microcrystalline cellulose magnesium, stearate, dicalcium phosphate, and silicone dioxide.
Locations (1)
University of Coloardo Anschutz Medical Campus
Aurora, Colorado, United States