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

Description

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.

Conditions

End Stage Renal Disease on Dialysis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
End Stage Renal Disease on Dialysis
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Jeffrey Testani, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2024-12-31