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NCT05671991
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Conditions: End Stage Renal Disease on Dialysis
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 30
Sponsor: Yale University
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 Criteria
Inclusion CriteriaPatients actively undergoing PD with a reliably functioning PD catheterStable peritoneal dialysis prescriptionChronic loop diuretic usage (at Yale, essentially all patients that make urine are on chronic loop diuretics)PD vintage > 3 months24 Hour urine output >400 mlAge >18 years of ageExclusion Criteria: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 monthsUse of an SGLT2 inhibitor within the prior 30 days1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheterAnemia with hemoglobin <8g/dLInability to give written informed consent or follow study protocol
Source: ClinicalTrials.gov (NCT05671991). StuddyBuddy aggregates publicly available trial information.