Actively Recruiting
Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients
Led by University of Colorado, Denver · Updated on 2025-05-29
80
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years
- Kidney transplant received at least 1 year before randomization
- Estimated glomerular filtration rate between 30 and 90 ml/min/1.73m2
- Urine albumin to creatinine ratio between 30 and 5000 mg/g
- Pre-existing type 2 diabetes or post-transplant diabetes mellitus
- Blood pressure less than 130/80 mm Hg before randomization
- Able to provide informed consent
- Stable immunosuppression for at least 3 months before baseline with tacrolimus, mycophenolate mofetil/mycophenolic acid, and prednisone
- Stable anti-hypertensive treatment for at least 1 month before baseline
- Stable diabetes management for at least 3 months before baseline
- Stable use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker for at least 3 months before baseline if applicable
- Stable use of glucagon-like peptide-1 receptor agonist for at least 3 months before baseline if applicable
You will not qualify if you...
- Type 1 diabetes
- Life expectancy less than 1 year
- Uncontrolled hypertension
- Hemoglobin A1c greater than 9%
- Body mass index over 40 kg/m2
- New York Heart Association Class 3 or 4 heart failure symptoms, ejection fraction 30% or less, 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
- Current urinary or urogenital infection
- Use of anticoagulants (contraindication for kidney biopsy)
- Contraindications to magnetic resonance imaging (MRI)
- History of lower-limb amputation from any cause
- Known allergy to dapagliflozin
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Jessica Kendrick
CONTACT
P
Petter Bjornstad
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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