NCT05510115Active, not recruitingPhase 2
Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 Aug 2022
- Start date
- 18 Nov 2022
- Primary completion date
- 18 Mar 2026
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Polycystic kidney disease
- NCT number
- NCT05510115
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 18 Nov 2022 to the primary completion date, 18 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known diabetes mellitus;
- Current urinary tract or urogenital infection;
- Vascular claudication, lower extremity skin infection or ulcers;
Lab values
- Fasting Glucose \>120 mg/dL;
- HbA1C≥6.5%;
- Known heart failure with reduced ejection fraction (HFrEF);
Other
- Seated systolic blood pressure \<100 mm Hg;
- Seated systolic blood pressure \>160 mm Hg;
- Current use of loop diuretic;
- Current use of tolvaptan or other V2 receptor antagonist;
- Pregnant or lactating;
- Contraindication to magnetic resonance imaging (e.g., severe claustrophobia, implanted ferromagnetic device).
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Coloardo Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
Related publications
- Empagliflozin Therapy in Autosomal Dominant Polycystic Kidney Disease: A Feasibility Randomized Controlled Trial.J Am Soc Nephrol · 2026 · PMID 42925875
- Cardiovascular-Kidney-Metabolic Syndrome in Autosomal Dominant Polycystic Kidney Disease.J Am Soc Nephrol · 2026 · PMID 42789922
This page is information, not medical advice. Discuss any trial with your doctor.