Empagliflozin for Polycystic Kidney Disease
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as loop diuretics and tolvaptan or other V2 receptor antagonists, before participating.
What data supports the effectiveness of the drug empagliflozin for treating polycystic kidney disease?
Is empagliflozin generally safe for humans?
Empagliflozin, also known as Jardiance, is generally well-tolerated in humans, but it can have side effects and contraindications. It has been studied for safety in people with type 2 diabetes and heart failure, showing it is safe for these conditions, though monitoring for side effects like fluid deficits is recommended.56789
How does the drug empagliflozin differ from other treatments for polycystic kidney disease?
Empagliflozin is unique because it is primarily used to treat type 2 diabetes by preventing glucose reabsorption in the kidneys, which also helps reduce blood pressure and body weight. Its potential use in polycystic kidney disease is novel, as it may help slow kidney disease progression, a benefit observed in chronic kidney disease patients.15101112
What is the purpose of this trial?
This trial tests empagliflozin, a drug that helps remove excess sugar through urine, in patients with ADPKD who suffer from kidney cysts and eventual kidney failure. The drug may help reduce kidney damage and improve heart health by blocking a protein that reabsorbs sugar. Empagliflozin has been shown to slow the progression of diabetic kidney disease.
Research Team
Michel B Chonchol, MD
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
This trial is for adults aged 18-50 with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and moderately reduced kidney function, but not diabetes or heart failure. Participants should have stable kidney health without recent infections and must not be pregnant, using certain diuretics, or have contraindications to MRI scans.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive empagliflozin or placebo in a 12-month parallel-group, randomized, double-blind, placebo-controlled trial
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Empagliflozin
- Placebo
Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Cardiovascular risk reduction
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
University of Maryland
Collaborator