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

Description

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.Autosomal dominant polycystic kidney disease (ADPKD) is characterized by development and continued growth of numerous fluid-filled kidney cysts that result in ultimate loss of kidney function in the majority of individuals. ADPKD manifestations are not limited to the kidney. It is well established that arterial stiffness, an important predictor of future cardiovascular events and mortality, is present early in the course of ADPKD. Sodium-glucose cotransporters-2 inhibitors (SGLT2i) have a track record of tolerability and safety in patients with diabetic and non-diabetic kidney disease. Studies of SGLT2i have been extremely encouraging and the expectation is that these treatme

Trial Eligibility

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Study Info

Interventions

Locations Recruiting

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