A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients
The purpose of this study is to assess Alefacept in combination with alemtuzumab induction and calcineurin inhibitor and corticosteroid withdrawal.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients|
- Incidence of first biopsy- proven acute rejection (Banff Grade≥ 1) (BCAR rate) and infections [ Time Frame: At 12 months post-transplant ] [ Designated as safety issue: Yes ]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.
- Affect on Immune cells [ Time Frame: Up to 12 months post-transplant ] [ Designated as safety issue: No ]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.
- Assess secondary outcome measures of efficacy and safety [ Time Frame: Upto 12 months post-transplant ] [ Designated as safety issue: Yes ]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
|Study Start Date:||July 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Alefacept (ASP0485)
Safety and efficacy of alefacept in combination with alemtuzumab induction and calcineurin inhibitor (CNI) and corticosteroid withdrawal.
Drug: Alefacept (ASP0485)
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.
Other Name: ASP0485
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.
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||M. Javeed Ansari, MD||Northwestern Universiy, Northwestern Memorial Hospital|