Empagliflozin Treatment in Kidney Transplant Recipients

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called empagliflozin in people who have received a kidney transplant and also have type 2 diabetes. The goal is to see if this treatment can help improve their heart and kidney health, as many kidney transplant recipients face long-term health challenges, especially related to heart disease. Empagliflozin has shown promise in helping patients with chronic kidney disease, but it hasn't been widely tested in kidney transplant recipients due to concerns about potential side effects.

To be eligible for this trial, participants need to be adults over 18 years old who have had a kidney transplant for at least three months and have a diagnosis of type 2 diabetes. They also need to be able to travel to a Veterans Affairs Medical Center for regular check-ups. During the trial, participants will receive the medication and be monitored closely by healthcare professionals. It's important to know that not everyone can participate; for example, individuals with certain health issues or those who have had complications related to diabetes may be excluded. Overall, this study aims to explore new ways to support the health of kidney transplant recipients with diabetes.

Gender

ALL

Eligibility criteria

• 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 \< 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).
• • 5. For subjects without T2DM or PTDM: measured kidney function by CKD epi eGFR must be 20mL/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).
• 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.