Actively Recruiting
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Led by Yale University · Updated on 2025-03-04
30
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis. This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.
CONDITIONS
Official Title
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients actively undergoing peritoneal dialysis with a reliably functioning PD catheter
- Stable peritoneal dialysis prescription
- On peritoneal dialysis for more than 3 months
- Age 18 years or older
You will not qualify if you...
- History of type 1 diabetes, diabetic ketoacidosis, brittle diabetes, or frequent severe hypoglycemia requiring emergency intervention in the last 6 months
- Use of an SGLT2 inhibitor within the prior 30 days
- One or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- Anemia with hemoglobin less than 8 g/dL
- Inability to give written informed consent or follow study protocol
- Contraindication to receiving loop diuretics
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
V
Veena Rao, PHD
CONTACT
K
Kara Otis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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