Using dapagliflozin to improve kidney and heart health in kidney transplant recipients
Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients
This study is testing if a diabetes medication called dapagliflozin can help improve kidney and heart health in adults who have had a kidney transplant.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06140537 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, in enhancing kidney function and cardiovascular health among adult kidney transplant recipients with type 2 diabetes or post-transplant diabetes. The study aims to address the high rates of cardiovascular disease and graft failure in this population by evaluating the drug's impact on long-term allograft function. Participants will receive either dapagliflozin or a placebo, and the trial will also explore the underlying mechanisms of action through innovative translational methods.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 who have received a kidney transplant at least one year prior and have type 2 diabetes or post-transplant diabetes.
Not a fit: Patients with type 1 diabetes or those with an anticipated life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney and cardiovascular health outcomes for kidney transplant recipients.
How similar studies have performed: Other studies have shown that SGLT2 inhibitors can lower cardiovascular and kidney disease risk in non-transplant populations, but data in kidney transplant recipients are limited, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Jessica Kendrick
- Email: Jessica.Kendrick@cuanschutz.edu
- Phone: 3037244837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.