Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease

Conditions

• Polycystic Kidney, Autosomal Dominant

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin — DRUG
  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 — DRUG
  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.

Study Details

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 Dates

Start date

Nov 18, 2022

Status verified

May 2025

Primary completion

Mar 18, 2026

Completion

Aug 1, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental
  Empagliflozin
• Placebo Comparator: Placebo comparator
  Placebo

Primary Outcome Measure

Safety of the intervention [ Time Frame: Baseline, check-in visits (every 2 weeks the 1st month, monthly on month 2 and 3 and then every 3 months until the end of the study), post-testing (12-months). ]

Locations (1)

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