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

NCT05510115 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Polycystic Kidney, Autosomal Dominant

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • University of Maryland

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Michel B Chonchol, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2026-03-18
Completion
2026-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05510115 on ClinicalTrials.gov