Actively Recruiting
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Led by Yale University · Updated on 2026-05-22
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates the effect of empagliflozin on peritoneal glucose absorption in patients with end stage renal disease (ESRD) who are on peritoneal dialysis. The study is a randomized, placebo-controlled, acute crossover trial involving about 30 chronic peritoneal dialysis patients. It aims to understand whether empagliflozin can reduce glucose absorption during dialysis and assess its impact on kidney function. Participants will first take a single dose of 25 mg empagliflozin or a matching placebo during the acute phase, with a crossover to the alternate treatment one week later. Following this, all participants will enter an 8-week open-label extension phase where they take 10 mg empagliflozin daily. Study visits and safety visits will include peritoneal equilibration tests (PET) and other assessments. Over approximately 9 weeks, participants will attend three main study visits and up to four safety visits. Researchers will measure glucose absorption, ultrafiltration volume, plasma glucose levels, natriuresis, peritoneal fluid inflammatory markers, PET parameters, and changes in body water. The study includes close safety monitoring and follow-up to evaluate treatment effects and kidney function.
CONDITIONS
Brief 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 catheter
- Stable peritoneal dialysis prescription
- Peritoneal dialysis treatment 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 severe hypoglycemic episodes needing emergency care in past 6 months
- Use of any SGLT2 inhibitor medication within the last 30 days
- One or more episodes of peritonitis or active infection of the dialysis catheter in the previous 6 months
- Anemia with hemoglobin less than 8 g/dL
- Unable to provide written informed consent or follow study procedures
- Contraindication to receiving loop diuretics
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 week
Participants receive a single dose of either 25 mg empagliflozin or placebo on Day 0, followed by the alternate treatment on Day 7 in a crossover design.
2 study visits (in-person)
Duration - 8 weeks
Participants take empagliflozin 10 mg daily for 8 weeks following the acute treatment phase.
1 baseline visit and weekly safety visits up to 8 weeks
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
V
Veena Rao, PHD
K
Kara Otis
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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