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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
30
Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
Chronic Study- Empagliflozin 10 mg for 8 weeks
Yale University
New Haven, Connecticut, United States
RECRUITINGGlucose absorption with empagliflozin vs. placebo
Total glucose absorption in grams with empagliflozin vs. placebo
Time frame: Day 0 to Day 63
Ultrafiltration volume with empagliflozin vs. placebo- acute study
Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.
Time frame: at 4 hours
Change in plasma glucose levels with empagliflozin vs. placebo- acute study
Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study
Time frame: Day 0 to Day 63
Increase in natriuresis with empagliflozin vs. placebo-acute study
Natriuresis determined by FENa
Time frame: Day 0 to Day 63
Change in peritoneal fluid inflammatory markers
Change in levels of IL-6 and CA-125 (in pg)
Time frame: Day 0 to Day 63
Change in PET test parameters
Change in peritoneal equilibration test parameters, measurement of solute transport across the peritoneal membrane (standard test carried out in PD patients to assess solute trasnport across membrane)
Time frame: Day 0 to Day 63
Change in total body water and extracellular water
Change in total body water and extracellular water, using heaving water (D20)
Time frame: Day 0 to Day 63
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