Empagliflozin Treatment in Kidney Transplant Recipients

Prior treatment

• History of prior pancreas transplant
• Acute rejection in the prior 3 months
• History of amputation due to peripheral vascular disease and/or diabetic foot ulcers within prior year
• Active pregnancy in a female transplant recipient

Other illness

• Uncontrolled type 2 diabetes mellitus with most recent A1C\>12%
• History of \>2 urinary tract infections per year or UTIs requiring admission in the last year, or urosepsis in the last year.
• Documented allergy to SGLT2i
• History of Type I diabetes mellitus
• History of diabetic ketoacidosis
• Severe congestive heart failure (NYHA functional class III or higher)
• Active mucocutaneous mycotic infection of the groin or external genitalia.
• History of malignancy except non-melanoma skin cancer within 2 years of screening
• Known of active current viral, fungal, mycobacterial, or other infections (including, but not limited to tuberculosis and atypical mycobacterial disease)
• HIV infected subjects, including those who are well controlled on anti-retrovirals
• Recent (within 6 months) Positive Hep B PCR or active disease
• Hepatitis C virus antibody positive (HCVAb+) subjects who have failed to demonstrate sustained viral remission for more than 12 weeks (after anti-viral treatment)
• A condition, in the eyes of the investigator, that precludes inclusion into the study.

Lab values

• 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

Other

• Inability or unwillingness of a participant to give written informed consent or comply with study protocol
• Use of SGLT2i within 90 days
• Indwelling foley catheter or urinary diversion
• Acute MACE event within 3 months of the study

• Adult (\>18 years of age) male and female recipients (all races and ethnicities)
• Subject must be able to understand and provide consent
• Recipient of a primary or secondary kidney transplant at least 3 months or longer since transplant
• 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).
• 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).