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

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.

CT.gov Identifier
NCT05671991
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Boehringer Ingelheim
Collaborator
Yale University
Study Contact Information
+49 61 32770
Recruiting
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Study Details

Diseases
Chronic Kidney Disease
Study Drug
Empagliflozin
Genes
N/A
Study Dates
Mar 2023 - Dec 2026
Sex
Female & Male
Age
18+ years
Inclusion and Exclusion Criteria
Inclusion 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

Protocol 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.

Study Locations

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