Delayed Graft Function Clinical Trial
Official title:
A Pilot Study Comparing the Safety and Efficacy of Zortress (Everolimus) With Low Dose Tacrolimus to Early Conversion to Calcineulin Inhibitor-Free Regimen and Mycophenolic Acid With Standard Dose Tacrolimus in Recipients of ECD/DCD Kidneys
The purpose of this pilot study is to evaluate concentration-controlled everolimus with low dose tacrolimus compared to early conversion to CNI-free regimen and MMF/MPA with standard dose tacrolimus in de novo renal transplant recipients of ECD/DCD kidneys. Given tacrolimus and MMF/MPA is a widely prescribed immunosuppressive regimen in the United States, comparisons of tacrolimus and MMF/MPA regimens to investigational therapies and treatment regimens are needed. Also, considering the fact that ECD/DCD is a fast growing fraction of donors, evaluation of various regimens' effects on rather delicate ECD/DCD kidneys is necessary.
The purpose of this pilot study is to evaluate concentration-controlled everolimus with low
dose tacrolimus compared to early conversion to CNI-free regimen and MMF/MPA with standard
dose tacrolimus in de novo renal transplant recipients of ECD/DCD kidneys. Given tacrolimus
and MMF/MPA is a widely prescribed immunosuppressive regimen in the United States,
comparisons of tacrolimus and MMF/MPA regimens to investigational therapies and treatment
regimens are needed. Also, considering the fact that ECD/DCD is a fast growing fraction of
donors, evaluation of various regimens' effects on rather delicate ECD/DCD kidneys is
necessary.
The primary objective of this study is to evaluate concentration-controlled everolimus and
low dose tacrolimus compared to MMF/MPA with standard dose tacrolimus at 24 months
post-transplant with respect to the composite efficacy failure rates (treated biopsy proven
acute rejection episodes (BPAR), graft loss, death, loss to follow-up) in de novo renal
transplant recipients.
The key secondary objective is to compare renal function of the everolimus treatment arms to
the MMF/MPA treatment arm at 12 and 24 months post-transplantation. Renal function will be
measured by the calculated glomerular filtration rate (GFR), using the MDRD (Modification of
Diet in Renal Disease) formula (20).
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