Feasibility of Study of Empagliflozin in Patients With ADPKD

Multiple locations

Overview
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.

Eligibility Criteria

  • Ages: 18 to 55 years old
  • ADPKD diagnosis defined by Pei-Ravine criteria
  • Estimated Glomerular Filtration Rate (eGFR) 30-90 ml/min/1.73m2
  • Mayo imaging-based risk classification 1C, 1D, or 1E
  • Stable renal function over the prior 3 months

Additional inclusion/exclusion criteria may apply

Participation

Participation will include check in visits every 2 weeks for the first month, monthly for months 2 and 3, and every 3 months until the end of the study. Outcomes will be measured at baseline, check-in visit (3 months), and post-testing (12 months) through MRI, venous blood samples, and the ADPKD impact scale.

Locations
Colorado

Principal Investigator: Michel Chonchol, MD

Collaborator: University of Maryland