NCT06140537 Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients
| NCT ID | NCT06140537 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Colorado, Denver |
| Condition | Kidney Transplant; Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2024-02-01 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06140537 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Kidney Transplant; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06140537 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06140537 currently recruiting?
Yes, NCT06140537 is actively recruiting participants. Contact the research team at Jessica.Kendrick@cuanschutz.edu for enrollment information.
Where is the NCT06140537 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06140537 clinical trial?
NCT06140537 is sponsored by University of Colorado, Denver. The trial plans to enroll 80 participants.
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