Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
- Conditions
- End Stage Renal Disease on Dialysis
- Interventions
- Registration Number
- NCT05671991
- Lead Sponsor
- Yale University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Empagliflozin or Placebo in Acute Empagliflozin 25 mg vs Placebo Acute phase: Participants will receive 25 mg empagliflozin once on Day 0 or Day 7. Participants receive empaglifozin or placebo on Day 0. On Day 7, they will be crossed over to the alternate treatment. Empagliflozin in Chronic Empagliflozin 10 MG Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks
- Primary Outcome Measures
Name Time Method Glucose absorption with empagliflozin vs. placebo Day 0 to Day 63 Total glucose absorption in grams with empagliflozin vs. placebo
- Secondary Outcome Measures
Name Time Method Ultrafiltration volume with empagliflozin vs. placebo- acute study at 4 hours Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.
Increase in natriuresis with empagliflozin vs. placebo-acute study Day 0 to Day 63 Natriuresis determined by FENa
Change in plasma glucose levels with empagliflozin vs. placebo- acute study Day 0 to Day 63 Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study
Change in peritoneal fluid inflammatory markers Day 0 to Day 63 Change in levels of IL-6 and CA-125 (in pg)
Change in total body water and extracellular water Day 0 to Day 63 Change in total body water and extracellular water, using heaving water (D20)
Change in PET test parameters Day 0 to Day 63 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)
Trial Locations
- Locations (1)
Yale University
🇺🇸New Haven, Connecticut, United States