Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients

Prior treatment

• Presence of severe peripheral vascular disease (i.e. prior amputation, gangrene, non-healing ulcer or ischemic rest pain);
• Presence of acute coronary syndrome, stroke or transient ischemic attack in the 3 months prior to screening;
• Prior episode of graft pyelonephritis in the 1 month prior to screening;
• Episode of acute graft rejection in the 3 months prior to screening;
• Initiation of a new immunosuppressive agent or discontinuation of an immunosuppressive agent in the 1 month prior to screening;
• Participation in another trial with an investigational drug within 30 days of informed consent;
• Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation;
• Patients currently using antipsychotic medications.
• Use of SGLT2 inhibitors within 1 month of starting the study.

Other illness

• Diagnosis of type 1 diabetes;
• Untreated urinary or genital tract infection;
• Any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement.

Other

• Severe hypoglycemia within 3 months of screening, or hypoglycemia unawareness;
• Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control;

• Male or females \>18 years old ≥ 6months after kidney transplantation;
• In patients with T2D or PTDM, HbA1c \<12.0%;
• eGFR ≥30 ml/min/1.73m\^2 (as per the CKD-EPI equation);
• BMI ≤45kg/m\^2;
• Blood pressure ≤160/90 and ≥90/60 at screening.