Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Overview
- Phase
- Phase 4
- Intervention
- Empagliflozin 25 mg vs Placebo
- Conditions
- End Stage Renal Disease on Dialysis
- Sponsor
- Yale University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Glucose absorption with empagliflozin vs. placebo
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion 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 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
Arms & Interventions
Empagliflozin or Placebo in Acute
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.
Intervention: Empagliflozin 25 mg vs Placebo
Empagliflozin in Chronic
Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks
Intervention: Empagliflozin 10 MG
Outcomes
Primary Outcomes
Glucose absorption with empagliflozin vs. placebo
Time Frame: Day 0 to Day 63
Total glucose absorption in grams with empagliflozin vs. placebo
Secondary Outcomes
- Ultrafiltration volume with empagliflozin vs. placebo- acute study(at 4 hours)
- Increase in natriuresis with empagliflozin vs. placebo-acute study(Day 0 to Day 63)
- Change in plasma glucose levels with empagliflozin vs. placebo- acute study(Day 0 to Day 63)
- Change in peritoneal fluid inflammatory markers(Day 0 to Day 63)
- Change in total body water and extracellular water(Day 0 to Day 63)
- Change in PET test parameters(Day 0 to Day 63)