Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients

Launched by UNIVERSITY OF COLORADO, DENVER · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called dapagliflozin on kidney function and heart health in adults who have received a kidney transplant. The goal is to see if this drug can help improve the health of the transplanted kidney and reduce the risk of heart disease, which is a common concern for kidney transplant recipients, especially those with diabetes. The trial is looking for participants who are between 18 and 80 years old, have had a kidney transplant at least a year ago, and have stable diabetes management.

If you join the study, you will be closely monitored to evaluate how well dapagliflozin works and to ensure your safety throughout the trial. You’ll need to be stable on your current medications for blood pressure and diabetes and meet specific health criteria. This research is important because it could lead to better treatments for kidney transplant patients, potentially improving their long-term health and quality of life. If you think you might be eligible or are interested in participating, please reach out for more information.

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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