Using dapagliflozin to improve kidney and heart health in kidney transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Jessica Kendrick
• Email: Jessica.Kendrick@cuanschutz.edu
• Phone: 3037244837

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.