A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT01163799|
Recruitment Status : Terminated (Noted increased risks, greater than expected for standard of care therapy.)
First Posted : July 16, 2010
Last Update Posted : May 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Transplant; Failure, Kidney||Drug: Alefacept (ASP0485)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||August 2012|
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
- Incidence of first biopsy- proven acute rejection (Banff Grade≥ 1) (BCAR rate) and infections [ Time Frame: At 12 months post-transplant ]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 ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163799
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||M. Javeed Ansari, MD||Northwestern Universiy, Northwestern Memorial Hospital|