Atherosclerosis Clinical Trial
Official title:
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
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in 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
well-being.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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