A Prospective, Randomized, Open-Label, Pilot Study To Compare The Effect On Carotid Atherosclerosis Of A Tacrolimus-Based Regimen With Conversion From A Tacrolimus- To A Sirolimus-Based Regimen At 3-4 Months Post-Transplant In De Novo Renal Transplant Recipients
A decision to terminate the study was taken in November 2011 and a communication to that
effect sent to all participating sites on November 18. All sites were asked to have patients
returned to the sites and have all end of study procedures performed by Dec 31, 2011.
The decision to terminate this study was made following the conduct of an interim analysis
which demonstrated that the study did not reach its primary endpoint. The termination of
this study was not driven by any safety concerns and had no impact on subject safety and
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Total Plaque Volume (TPV) Annual Rate of Change From Pre-conversion Baseline to 12 Months Post Transplant
Annual rate of change in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.
12 Months Post-Transplant
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