Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease (EMPA-PD)

Yale University

Status and phase: Enrolling; Phase 4

Conditions: End Stage Renal Disease on Dialysis

Treatments: Drug: Empagliflozin 10 MG; Drug: Empagliflozin 25 mg vs Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05671991

2000031605

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Empagliflozin or Placebo in Acute

Experimental group

Description:

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.

Treatment:

Drug: Empagliflozin 25 mg vs Placebo

Empagliflozin in Chronic

Active Comparator group

Description:

Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks

Treatment:

Drug: Empagliflozin 10 MG