About this trial
Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Sodium-glucose cotransporter 2 (SGLT2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in KTRs are lacking. This clinical trial seeks to establish the efficacy and safety of dapagliflozin, a SGLT2 inhibitor, for improving cardiovascular and kidney graft function in adult KTRs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.
Eligibility criteria
Qualifiers
Age 18-80 years
Kidney transplant received 1 year prior to randomization
estimated glomerular filtration rate 30-90 ml/min/1.73m2
Urine albumin to creatinine ratio (ACR) 30-5000 mg/g
Disqualifiers
Type 1 diabetes
Anticipated life expectancy <1 year
Uncontrolled hypertension
Hemoglobin A1c >9%
Trial design
Treatments tested in this trial
- Dapagliflozin 10mg Tab
- Placebo