Clinical trial NCT05671991: Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Official title: Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: End Stage Renal Disease on Dialysis
Keywords: Peritoneal dialysis
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2023-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, placebo controlled, acute crossover study of empagliflozin in 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.
Primary purpose: OTHER

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.

Eligibility criteria: 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 infection of the peritoneal dialysis catheter
4. Anemia with hemoglobin \<8g/dL
5. Inability to give written informed consent or follow study protocol
6. Contraindication to receiving loop diuretics

Primary outcomes:
measure: Glucose absorption with empagliflozin vs. placebo
timeFrame: Day 0 to Day 63
Secondary outcomes:
measure: Ultrafiltration volume with empagliflozin vs. placebo- acute study
timeFrame: at 4 hours
measure: Change in plasma glucose levels with empagliflozin vs. placebo- acute study
timeFrame: Day 0 to Day 63
measure: Increase in natriuresis with empagliflozin vs. placebo-acute study
timeFrame: Day 0 to Day 63
measure: Change in peritoneal fluid inflammatory markers
timeFrame: Day 0 to Day 63
measure: Change in PET test parameters
timeFrame: Day 0 to Day 63
measure: Change in total body water and extracellular water
timeFrame: Day 0 to Day 63
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Jeffrey Testani, MD
role: PRINCIPAL_INVESTIGATOR
References: