RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05671991

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 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. 2. Use of an SGLT2 inhibitor within the prior 30 days
  3. 3. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
  4. 4. Anemia with hemoglobin \<8g/dL
  5. 5. Inability to give written informed consent or follow study protocol
  6. 6. Contraindication to receiving loop diuretics

Contacts and Locations

Study Contact

Veena Rao, PHD
CONTACT
203-737-3571
veena.s.rao@yale.edu
Kara Otis
CONTACT
203-737-3571
kara.otis@yale.edu

Principal Investigator

Jeffrey Testani, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale University
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Jeffrey Testani, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Peritoneal dialysis

Additional Relevant MeSH Terms

  • End Stage Renal Disease on Dialysis