Polycystic Kidney, Autosomal Dominant Clinical Trial
Official title:
Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease
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 | Recruiting |
Enrollment | 50 |
Est. completion date | March 31, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
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). |
Country | Name | City | State |
---|---|---|---|
United States | University of Coloardo Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | University of Maryland |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events | Safety will be assessed by recording of adverse events. | 12 months | |
Primary | Subject Drop Out Rate | Tolerability will be assessed by subject drop-out rate due to adverse events and maximal tolerated dose. | 12 months | |
Primary | Returned Number of Tablets | Adherence to the intervention will be assessed by counting the returned number of tablets during check-in visits. | 12 months | |
Secondary | Height-Adjusted Total kidney volume | To assess kidney growth, we will measure change in height-adjusted total kidney volume by magnetic resonance imaging at baseline, 3 months and 12 months. | Baseline, check-in visit (3 months), post-testing (12-months) | |
Secondary | Aortic Pulse Wave Velocity (aPWV) | A transcutaneous custom tonometer (SphygmoCor XCEL PWA and PWV System; Atcor Medical Inc, Naperville IL) will be positioned at the carotid and femoral arteries and aPWV will be calculated as the distance between recording sites/time between the foot of the carotid and femoral arterial waveforms. Data will be expressed as cm/s. | Baseline, check-in visit (3 months), post-testing (12 months) | |
Secondary | Mechanistic Biomarkers | Venous blood samples will be analyzed for the following circulating mechanistic biomarker: Plasma copeptin.
Urine samples will be analyzed for the following mechanistic biomarker: Kidney Injury Molecule -1 (KIM-1). |
Baseline, check-in visit (3 months), post-testing (12 months) | |
Secondary | Patient Related Outcomes | The ADPKD Impact Scale (ADPKD-IS) includes 18 items representing 3 distinct domains (physical function, fatigue, and emotional function | 12 months |
Status | Clinical Trial | Phase | |
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