Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Yale University
30 participants
Mar 1, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Patients actively undergoing PD with a reliably functioning PD catheter
- Stable peritoneal dialysis prescription
- PD vintage > 3 months
- Age >18 years of age
Exclusion Criteria6
- History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
- Use of an SGLT2 inhibitor within the prior 30 days
- 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- Anemia with hemoglobin <8g/dL
- Inability to give written informed consent or follow study protocol
- Contraindication to receiving loop diuretics
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Interventions
Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
Chronic Study- Empagliflozin 10 mg for 8 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05671991