Active — Not RecruitingPhase 2

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

United States50 participantsStarted 2022-11-18

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Safety of the intervention

Timeframe: 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).

Tolerability and adherence of the intervention

Timeframe: 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).

Trial details

NCT IDNCT05510115

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-18

View on ClinicalTrials.gov More Polycystic Kidney, Autosomal Dominant trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety of the intervention

Timeframe: 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).

Tolerability and adherence of the intervention

Timeframe: 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).