A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients

This is a single center, investigator initiated, pilot study to assess the safety and
efficacy of Alefacept in combination with Alemtuzumab induction and Myfortic with rapid
steroid and calcineurin inhibitor withdrawal in de novo kidney transplant recipients.
Induction therapy involves a single dose of Alemtuzumab and steroids perioperatively.
Tacrolimus will be administered for the first 30 days post-transplantation. Alefacept will
be administered IV for the first two doses followed by subcutaneous injections weekly until
12 weeks post-transplant, followed by monthly injections for the rest of the duration of the
study. The primary outcomes are safety and efficacy, including biopsy proven acute rejection
episodes, infectious complications or other serious adverse events. Secondary outcomes
include T-helper cell differentiation, cytokine production and T regulatory cell generation
assessed by immune monitoring assays.