Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients
Eligible age
18–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Colorado, Denver
You may qualify if…
- ✓ 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
- ✓ Pre-existing type 2 diabetes or post-transplant diabetes mellitus
- ✓ Blood pressure \<130/80 mm Hg prior to randomization
- ✓ Able to provide informed consent
- ✓ Stable immunosuppression for at least 3 months prior to baseline consisting of tacrolimus, mycophenolate mofetil/mycophenolic acid and prednisone
You may not qualify if…
- ✕ Type 1 diabetes
- ✕ Anticipated life expectancy \<1 year
- ✕ Uncontrolled hypertension
- ✕ Hemoglobin A1c \>9%
- ✕ Body mass index \>40 kg/m2
- ✕ New York Heart Association Class 3 or 4 heart failure symptoms, an EF ≤30%, or hospitalization for heart failure in the past 3 months
- ✕ Pregnancy, plans to become pregnant, or breastfeeding
- ✕ Current use of sodium glucose cotransporter-2 (SGLT2) inhibitors
Where it's recruiting
Aurora
Source: ClinicalTrials.gov · NCT06140537 · last updated 2025-05-29