RECRUITING

Empagliflozin in ESKD - A Feasibility Study

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 aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on dialysis. The use of empagliflozin has not been studied or approved among patients on dialysis for kidney failure because empagliflozin acts on the kidneys. However, recent experimental studies have indicated that empagliflozin may provide direct heart benefits. Some dialysis patients have substantial residual kidney function, which may be protected by empagliflozin. Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for participants' condition) and will be followed up until one (1) month after the last dose. The investigators will collect information about participants' general health, obtain blood, urine, and imaging studies, check home blood pressure, monitor home blood sugar levels, and ask health-related questions to assess the safety and potential benefits of empagliflozin over four (4) months, including one month before the three (3)-month empagliflozin treatment.

Official Title

Empagliflozin in ESKD - A Feasibility Study

Quick Facts

Study Start:2023-11-01
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05687058

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. 1. age ≥18 years;
  2. 2. diagnosis of end-stage kidney disease requiring dialysis, and
  3. 3. ability to provide informed consent.
  1. 1. systolic blood pressure \<100 mm Hg (pre-dialysis for HD patients)
  2. 2. two or more episodes of urinary tract infection within the last 12 months
  3. 3. history of urinary retention or urinary tract obstruction
  4. 4. liver cirrhosis
  5. 5. advanced heart failure requiring heart assist device or inotropic support
  6. 6. heart or liver transplant recipient
  7. 7. major surgery performed within the last 3 months ("major" per the investigator's assessment)
  8. 8. major surgery scheduled within 3 months after screening ("major" per the investigator's assessment)
  9. 9. active cancer
  10. 10. pregnant or lactating women
  11. 11. known allergy or hypersensitivity to any SGLT2 inhibitors
  12. 12. history of ketoacidosis during the last 12 months
  13. 13. any other medical condition considered unappropriated by their nephrologists or a study physician (i.e., cachexia, short life expectancy, or uncontrolled personality/phycological disorder).

Contacts and Locations

Study Contact

Yoshitsugu Obi, MD, PhD
CONTACT
601-984-5670
yobi@umc.edu
Amy J Wigglesworth, RN
CONTACT
601-815-3464
ajwigglesworth@umc.edu

Principal Investigator

Yoshitsugu Obi, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Mississippi Medical Center

Study Locations (Sites)

University of Mississippi Medical Center
Jackson, Mississippi, 39157
United States
Jackson Medicall Mall Dialysis Clinic
Jackson, Mississippi, 39213
United States

Collaborators and Investigators

Sponsor: University of Mississippi Medical Center

  • Yoshitsugu Obi, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Mississippi Medical Center

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 Date2023-11-01
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • empagliflozin
  • end-stage kidney disease
  • pharmacokinetics
  • pharmacodynamics
  • feasibility trial
  • heart failure
  • residual kidney function
  • Sodium-glucose transporter type 2 inhibitor

Additional Relevant MeSH Terms

  • Kidney Failure, Chronic
  • Heart Failure