Using Empagliflozin to Improve Outcomes in Kidney Transplant Recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of the SGLT2 inhibitor Empagliflozin in veterans who have received kidney transplants. It aims to determine whether this medication can improve graft function and cardiovascular health in kidney transplant recipients, particularly those with chronic kidney disease and diabetes. Participants must be at least three months post-transplant and meet specific kidney function criteria. The study will monitor the effects of Empagliflozin on patient outcomes over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult (\>18 years of age) male and female recipients (all races and ethnicities)
2. Subject must be able to understand and provide consent
3. Recipient of a primary or secondary kidney transplant at least 3 months or longer since transplant
4. For subjects with T2DM or post-transplant diabetes (PTDM), measured kidney function by CKD epi eGFR must be 30mL/min/1.73m2 to 59 mL/min/1.73m2 or CKD epi eGFR 60 mL/min/1.73m2 with urinary albumin:creatinine ratio 30 mg/g (or protein:creatinine 100 mg/g).
5. For subjects without T2DM or PTDM: measured kidney function by CKD epi eGFR must be 20mL/min/1.73m2 to 59mL/min/1.73m2 or CKD epi eGFR 60 mL/min/1.73m2 with urinary albumin:creatinine ratio 30 mg/g (or protein:creatinine 100 mg/g).

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
2. History of prior pancreas transplant
3. CKD epi eGFR \< 30 mL/min/1.73m2 for those with T2DM or \< 20 mL/min/1.73m2 for those without T2DM or anyone with 5mL/min/1.73m2 fall in eGFR per year
4. Uncontrolled type 2 diabetes mellitus with most recent A1C\>12%
5. History of \>2 urinary tract infections per year or UTIs requiring admission in the last year, or urosepsis in the last year.
6. Use of SGLT2i within 90 days
7. Documented allergy to SGLT2i
8. History of Type I diabetes mellitus
9. History of diabetic ketoacidosis
10. Indwelling foley catheter or urinary diversion
11. Acute rejection in the prior 3 months
12. Acute MACE event within 3 months of the study
13. Severe congestive heart failure (NYHA functional class III or higher)
14. Active mucocutaneous mycotic infection of the groin or external genitalia.
15. History of amputation due to peripheral vascular disease and/or diabetic foot ulcers within prior year
16. History of malignancy except non-melanoma skin cancer within 2 years of screening
17. Known of active current viral, fungal, mycobacterial, or other infections (including, but not limited to tuberculosis and atypical mycobacterial disease)
18. HIV infected subjects, including those who are well controlled on anti-retrovirals
19. Recent (within 6 months) Positive Hep B PCR or active disease
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. Active pregnancy in a female transplant recipient
22. A condition, in the eyes of the investigator, that precludes inclusion into the study.

Where it's running

• Edward Hines Jr. VA Hospital, Hines, IL
  Hines, Illinois, United States Recruiting
• Iowa City VA Health Care System, Iowa City, IA
  Iowa City, Iowa, United States Recruiting
• Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
  Omaha, Nebraska, United States Recruiting
• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  Pittsburgh, Pennsylvania, United States Recruiting
• Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Roslyn B Mannon, MD — Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
• Study coordinator: Roslyn B Mannon, MD
• Email: roslyn.mannon@va.gov
• Phone: (205) 999-7362

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.