The purpose of this study is to assess Alefacept in combination with alemtuzumab induction and calcineurin inhibitor and corticosteroid withdrawal.
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 single dose Alemtuzumab and steroids peri-operatively. 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 outcomes, including biopsy proven acute rejection episodes, infectious complications or other serious adverse events. Secondary outcomes include T-helper differentiation, cytokine production and T regulatory cell generation assessed by immune monitoring assays.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Withdrawal of calcineurin inhibitor at 30 days post-transplant. Administer Alefacept 7.5 mg post-op day 0, post-op day 2 given IV; Alefacept 15 mg SQ X 12 weeks, then monthly until Month 12.
Northwestern Memorial Hospital
Chicago, Illinois, United States
Incidence of first biopsy- proven acute rejection (Banff Grade≥ 1) (BCAR rate) and infections
To assess the safety and efficacy of alefacept in combination with a single dose of alemtuzamab induction and Enteric coated Mycophenolic sodium with calcineurin inhibitor withdrawal and rapid elimination of corticosteroids by examining the incidence of first biopsy-proven acute rejection (Banff Grade≥ 1) (BCAR rate) and the incidence and clinical presentation of infections.
Time frame: At 12 months post-transplant
Affect on Immune cells
To assess how alefacept affects T-cell differentiation, memory, and immunoregulatory T-cell homeostasis, B-cells and cytokine/chemokine profile by using various immune monitoring assays.
Time frame: Up to 12 months post-transplant
Assess secondary outcome measures of efficacy and safety
At 12 months: Patient/graft survival rates, BCAR rate, Maximum grade of acute rejection with BCAR, Incidence of clinically-treated acute rejections, Incidence of anti-lymphocyte antibody therapy for treatment of rejection, Incidence of multiple rejection episodes, Incidence of treatment failure (defined as death, graft loss, biopsy-confirmed acute rejection, lost to follow-up or early discontinuation of treatment regimen), Incidence of leucopenia, Incidence of bacterial, fungal, viral, or parasitic infection. At 6 \& 12 months: Serum creatinine, GFR by iohexol clearance. Time to first BCAR
Time frame: Upto 12 months post-transplant
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