Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease

• Status: Not yet recruiting
• Trial end date: 2024-07-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Boehringer Ingelheim
• Treatments: Empagliflozin

Criteria

Inclusion Criteria

1. Patients actively undergoing PD with a reliably functioning PD catheter

2. Stable peritoneal dialysis prescription

3. Chronic loop diuretic usage (at Yale, essentially all patients that make urine are on chronic loop diuretics)

4. PD vintage > 3 months

5. 24 Hour urine output >400 ml

6. 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