Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease (NCT05510115) | Clinical Trial Compass
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 range
18 Years – 55 Years
Sex
ALL
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).
2
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).