Cardiovascular Diseases Clinical Trial
Official title:
A One-Year, Prospective, Randomized, Controlled Study Evaluating The Efficacy Of Switching From The Twice Daily Tacrolimus Formulation To The Extended Release, Once Daily Formulation To Reduce The Framingham Cardiovascular Risk Scores.
Current standard prophylactic immunosuppression in renal transplantation includes tacrolimus,
a calcineurin inhibitor, dosed twice daily. In Canada, oral tacrolimus has been available as
a twice daily formulation marketed as Prograf® since 1997. It has recently become available
in an extended release formulation called Advagraf®, which is dosed once daily. Advagraf® has
been demonstrated to be therapeutically equivalent to Prograf® in the renal transplant
maintenance population, and as a result it has been is approved as an alternative to the
twice daily formulation in these patients. There is an evolving and expanding positive
clinical experience with Advagraf® in kidney transplantation and it has shown to be preferred
by many patients, due to the diminished dosing frequency. In clinical trials, Advagraf® has
been shown to have other potential benefits over Prograf® such as less inter and
intra-patient variability, improved cardiovascular profiles, and improved kidney function.
Compared to Prograf®, Advagraf® also has a lower Cmin or 'trough' concentration as well as a
lower Cmax or 'peak' concentration. The purpose of this study is to convert stabilized renal
transplant patients currently receiving Prograf® to Advagraf®, to investigate these potential
therapeutic benefits.
The Framingham Risk Score and the Reynold's Risk Score are currently recommended by the
Canadian Cardiovascular Society (CCS) to predict 10-year cardiovascular risk in the general
population. Surrogate markers are widely used in clinical trials to shorten follow-up
durations. In this study, the investigators will use the Framingham Risk Score and Reynold's
Risk Score to quantify changes in estimated cardiovascular risk. The investigators also
intend to examine novel inflammatory markers to investigate cardiovascular risk.
The investigators hypothesize that the more consistent drug exposure and lower Cmax noted
with Advagraf® will decrease Framingham Risk Score, Reynolds Risk score as well as markers of
inflammation in kidney transplant recipients.
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