Autoimmune Diseases Clinical Trial
Official title:
A Pilot Trial to Assess the Effect of CNI Conversion to Efalizumab in T Regulatory Cells in Renal Transplantation
The purpose of this pilot trial is to determine whether a conversion from calcineurin inhibitors (CNI) and mycophenolate mofetil (MMF) to a regimen consisting of efalizumab and sirolimus is associated with an increase in T regulatory cells, white cells that control the immune system and can prevent autoimmune diseases like arthritis or rejection of foreign organs,and does not result in an increase in acute rejection.
The objective of this pilot trial is to determine whether the conversion from calcineurin
inhibitors (CNI) and mycophenolate mofetil (MMF) to efalizumab and sirolimus is associated
with an increase in T regulatory cells and does not result in an increase in acute rejection
following conversion. CNIs are associated with progressive nephrotoxicity, increased
cardiovascular risk factor as well as an inhibitory effect on T regulatory cells.
PRIMARY OBJECTIVE:
To determine if the combination of efalizumab and sirolimus results in a significant
increase in T regulatory cells. A hundred percent increase in T regulatory cells will be
determined to be an important biologic effect of the combination of efalizumab and
sirolimus.
SECONDARY OBJECTIVES:
To assess the feasibility of the conversion from CNI/MMF to efalizumab/sirolimus and to
determine that this combination is safe and effective
To determine if there is an increase in FoxP3 mRNA in the urine of converted patients. Urine
FoxP3 is believed to correlate with T regs in the kidney.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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