Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
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.
Description
Participants will undergo three study visits, and up to 4 safety visits, over 9 weeks. At 7 AM in the first study visit, the participants will have taken 25mg empagliflozin once or matching placebo, thus producing peak plasma levels by 10 AM. One week later the participant will return for the crossed over to the alternate study drug. At the conclusion of the 2nd study visit, all participants will be provided with empagliflozin 10mg tabs to be taken daily for 56 days (8 weeks). At each study visit and safety visit, participants will undergo a PET test.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Patients actively undergoing PD with a reliably functioning PD catheter 2. Stable peritoneal dialysis prescription 3. PD vintage \> 3 months 4. Age \>18 years of age Exclusion Criteria: 1. 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 2. Use of an SGLT2 inhibitor within the prior 30 days 3. 1 or more episodes of peritonitis in the previous 6 months or active infecti…
Interventions
- DrugEmpagliflozin 25 mg vs Placebo
Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
- DrugEmpagliflozin 10 MG
Chronic Study- Empagliflozin 10 mg for 8 weeks
Location
- Yale UniversityNew Haven, Connecticut