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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Polycystic Kidney, Autosomal Dominant

In brief

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 facts

Study ID

NCT05510115

Run by

University of Colorado, Denver

People needed

50

Starts

2022-11-18

Expected to finish

2026-08-01

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Autosomal Dominant Polycystic Kidney Disease (ADPKD) as defined by modified Pei-Ravine Criteria;
• Age 18-55 yrs;
• Estimated Glomerular Filtration Rate (eGFR) 30-90 ml/min/1.73m2;
• Mayo imaging-based risk classification 1C, 1D, or 1E;
• Stable renal function over prior 3 months.

You may not qualify if…

• Known diabetes mellitus;
• Fasting Glucose >120 mg/dL;
• HbA1C≥6.5%;
• Seated systolic blood pressure <100 mm Hg;
• Seated systolic blood pressure >160 mm Hg;
• Known heart failure with reduced ejection fraction (HFrEF);
• Current use of loop diuretic;
• Current use of tolvaptan or other V2 receptor antagonist;
• Current urinary tract or urogenital infection;
• Pregnant or lactating;
• Vascular claudication, lower extremity skin infection or ulcers;
• Contraindication to magnetic resonance imaging (e.g., severe claustrophobia, implanted ferromagnetic device).

Where it is running

• University of Coloardo Anschutz Medical Campus — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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