NCT02058875

Cardiovascular Risk Following Conversion to Full Dose Myfortic® and Neoral® Two-hour Post Level Monitoring

Comparisons Of Inflammatory Biomarkers And Cardiovascular Risk Scores Before And After Conversion To Full Dose Myfortic® Using Two Hour Neoral® Monitoring.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cardiovascular Disease
• Cardiovascular Outcomes
• Kidney Transplant Recipients
• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Myfortic®
DRUG	Neoral®
DRUG	Cellcept®
DRUG	Prednisone

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-02-10
• Last updated: 2017-01-09

Locations

2 sites across 1 country: Canada