Status:
RECRUITING
Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients
Lead Sponsor:
University of Colorado, Denver
Conditions:
Kidney Transplant; Complications
Vascular Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- Stable anti-hypertensive regimen for at least 1month prior to baseline
- Stable diabetes management for at least 3 months prior to baseline
- Stable angiotensin converting enzyme inhibitor/angiotensin receptor blocker use for at least 3 months prior to baseline (if applicable)
- Glucagon-like peptide-1 receptor agonist (GLP-1RA) for at least 3 months prior to baseline (if applicable)
Exclusion
- 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
- Current urinary or urogenital infection
- Use of anticoagulants (contraindication to kidney biopsy)
- Magnetic resonance imaging (MRI) contraindications
- History of lower-limb amputation irrespective of etiology
- Known hypersensitivity to dapagliflozin
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06140537
Start Date
February 1 2024
End Date
December 31 2028
Last Update
May 29 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045