Cardiovascular Disease Clinical Trial
Official title:
Comparisons Of Inflammatory Biomarkers And Cardiovascular Risk Scores Before And After Conversion To Full Dose Myfortic® Using Two Hour Neoral® Monitoring.
The overall goal of this study is to improve cardiovascular outcomes in transplant recipients. The current standard immunosuppressive regimen in kidney transplant recipients depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than optimal dosage the of mycophenolic acid (MPA) derivative. The premise of this study is to investigate the effects of reversing this paradigm. More specifically, the effect of using maximum MPA dosages (in the form of enteric-coated mycophenolate sodium [EC-MPS] or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) will be investigated.
Research Question:
Will treating kidney transplant recipients with maximum MPA dosages (in the form of EC-MPS
or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) lead to improved
cardiovascular outcomes, as measured by the Framingham Risk Score, 7-year major adverse
cardiac events (MACE) score and cardiovascular risk inflammatory biomarker profile?
Primary Objectives:
1. To improve the Framingham Risk Score and 7-year MACE score for renal transplant
recipients, which estimate risk for cardiovascular disease.
2. To improve the cardiovascular risk inflammatory biomarker profile.
Hypothesis:
The more consistent drug exposure and lower Cmax noted with monitoring cyclosporine using
the 2h levels (C2) combined with full dose Myfortic® will decrease Framingham Risk Score,
MACE score, as well as markers of inflammation in kidney transplant recipients because:
1. CNI minimization protocols are widely accepted as a strategy to ameliorate allograft
and vascular injury.
2. Chronic allograft injury and vascular disease are known inflammatory conditions.
3. The MPA derivatives possess significant anti-inflammatory properties.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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