Loading clinical trials...
Loading clinical trials...
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.
Age
18 - 74 years
Sex
ALL
Healthy Volunteers
No
Kidney Health Center
Regina, Saskatchewan, Canada
St. Paul's Hospital
Saskatoon, Saskatchewan, Canada
Start Date
February 1, 2014
Primary Completion Date
October 1, 2015
Completion Date
October 1, 2015
Last Updated
January 9, 2017
Myfortic®
DRUG
Neoral®
DRUG
Cellcept®
DRUG
Prednisone
DRUG
Lead Sponsor
University of Saskatchewan
NCT03372733
NCT05702398
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07241390