RECRUITING

Empagliflozin Treatment in Kidney Transplant Recipients

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

Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors. There has been little progress in improving outcomes in this area for over two decades. Recent studies in chronic kidney disease (CKD) patients using SGLT2 inhibitors (SGLT2i), regardless of the presence of type 2 diabetes mellitus (T2DM), results in both kidney protective and cardiac protective impacts and improved patient outcomes. However, kidney transplant recipients (KTRs) were excluded from these clinical trials due to concerns that these agents promote infection, diminish graft function, and may alter immunosuppressive drug levels that are the mainstay of patient's transplant therapy. There are limited published data of SGLT2i treatment of selected KTRs.

Official Title

An Exploratory Investigation of the Safety of Empagliflozin in Kidney Transplant Recipients (SEKTR)

Quick Facts

Study Start:2024-04-05
Study Completion:2030-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06013865

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:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult (\>18 years of age) male and female recipients (all races and ethnicities)
  2. 2. Subject must be able to understand and provide consent
  3. 3. Recipient of a primary or secondary kidney transplant at least 3 months or longer since transplant
  4. 4. Subject must have a diagnosis of Type 2 Diabetes Mellitus or post-transplant diabetes mellitus (PTDM) 2DM or PTDM
  5. 5. Subject must be able to travel to and from VAMC for care and monitoring
  6. 6. Subject must have kidney function measured by CKD epi eGFR 30 mL/min/1.73m2 to \< 45ml/min/1.73m2 or CKD epi eGFR 45 mL/min/1.73m2 to 90ml/min/1.73m2 with urinary albumin:creatinine ratio 200 mg/g (or protein:creatinine 300 mg/g).
  1. 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  2. 2. History of prior pancreas transplant
  3. 3. CKD epi eGFR\< 30 mL/min/1.73m2 with 5mL/min/1.73m2 fall per year
  4. 4. Uncontrolled type 2 diabetes mellitus with most recent A1C\>12%
  5. 5. History of \>2 urinary tract infections per year or UTIs requiring admission in the last year, or urosepsis in the last year.
  6. 6. Use of SGLT2i within 90 days
  7. 7. Documented allergy to SGLT2i
  8. 8. History of Type I diabetes mellitus
  9. 9. History of diabetic ketoacidosis
  10. 10. Indwelling foley catheter or urinary diversion
  11. 11. Acute rejection in the prior 3 months
  12. 12. Acute MACE event within 3 months of the study
  13. 13. Severe congestive heart failure (NYHA functional class III or higher)
  14. 14. Active mucocutaneous mycotic infection of the groin or external genitalia.
  15. 15. History of amputation due to peripheral vascular disease and/or diabetic foot ulcers within prior year
  16. 16. History of malignancy except non-melanoma skin cancer within 5 years of screening
  17. 17. Known active current viral, fungal, mycobacterial, or other infections (including, but not limited to tuberculosis and atypical mycobacterial disease)
  18. 18. HIV infected subjects, including those who are well controlled on anti-retrovirals
  19. 19. Positive Hep B PCR
  20. 20. Hepatitis C virus antibody positive (HCVAb+) subjects who have failed to demonstrate sustained viral remission for more than 12 weeks (after anti-viral treatment)
  21. 21. Active pregnancy in a female transplant recipient

Contacts and Locations

Study Contact

Roslyn B Mannon, MD
CONTACT
(205) 999-7362
roslyn.mannon@va.gov
Ramesh K Ramalingam
CONTACT
(402) 995-4873
Ramesh.Ramalingam@va.gov

Principal Investigator

Roslyn B Mannon, MD
PRINCIPAL_INVESTIGATOR
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Study Locations (Sites)

Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2292
United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Roslyn B Mannon, MD, PRINCIPAL_INVESTIGATOR, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

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 Date2024-04-05
Study Completion Date2030-03-31

Study Record Updates

Study Start Date2024-04-05
Study Completion Date2030-03-31

Terms related to this study

Keywords Provided by Researchers

  • Transplant
  • Diabetes
  • Kidney Failure
  • Rejection

Additional Relevant MeSH Terms

  • Kidney Transplant
  • Type 2 Diabetes