| Outcome Measures: |
Primary: Discontinuation of Empagliflozin, The incidence of therapeutic discontinuation of empagliflozin in the kidney transplant recipient from time of initiation., about 2 years | Secondary: Infection, Defined as the cumulative incidence of study defined Grade 3 or higher infection of the urinary tract or perineum after initiation of treatment., about 2 years|Hypoglycemia, The cumulative incidence of grade 3 hypoglycemia, about 2 years|Major cardiorenal events, Time to first occurrence of the composite of major adverse cardiorenal events (MACER) as defined as all-cause mortality, stroke, non-fatal myocardial infarction, heart failure events including hospitalization for CHF or urgent CHF treatment, sustained (for at least 3 months) 40% decline in eGFR, or allograft failure as defined by chronic dialysis, re-transplantation, or persistent eGFR \<15mL/min/1.73m2), about 2 years|Acute Graft Dysfunction, The cumulative incidence of \>15% elevation in serum creatinine for more than 4 weeks from the baseline defined prior to treatment., about 2 years|Volume Depletion, The cumulative incidence of grade 3 volume depletion., about 2 years|Acute Cellular Rejection, The cumulative incidence of acute rejection biopsy proven using 2017 criteria: Type IA Moderate tubulitis and at least moderate interstitial inflammation t2i2 or t2i3 Type IB Severe tubulitis and at least moderate interstitial inflammation t3i2 or t3i3 Type IIA Mild to moderate intimal arteritis v1 Type IIB Severe intimal arteritis (\> 25% of the luminal area) v2 Type III Transmural' arteritis and/or fibrinoid necrosis v3 Borderline: no intimal arteritis is present, t\>0 and i1 or i2/i3 and t1, about 2 years|Amputation and foot ulceration, The cumulative incidence of Grade 3 foot ulceration and/or need for amputation., About 2 years|Proteinuria, Spot Urine Protein/creatinine ratio, 12 and 24 months|Allograft Biopsy, Time to incidence of a decline in eGFR sufficient to trigger a clinical decision for an allograft biopsy, about 2 years|MACER, Time to first occurrence of individual component of the MACER secondary outcome, about 2 years|Death, Time to the occurrence of cardiovascular death, about 2 years|Acute graft dysfunction, Time to acute kidney injury as defined as a \>15% change in eGFR from baseline, About 2 years|Slope of kidney function, Serum creatinine measured in mg/dL for all participants prior to treatment, at month 6, month 12 and month 24 of treatment., over 2 years|Glycemic Control, Changes in Hemoglobin A1C over time of treatment, over 2 years|Body Weight, Change in body weight over time of treatment, over 2 years|Blood Pressure, Change in blood pressure measured in mmHg over the course of the study, over 2 years
|
| Locations: |
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
|
