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Keep this study
Lead
Astellas Pharma Inc
This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure
Subject is a recipient of a de novo kidney transplant
Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical related living donor, a non-related living donor, or a deceased donor
You may not be if
Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+ T-cell count of \< 250 cells/µL
Subject will receive a kidney with an anticipated cold ischemia time (CIT) of \> 30 hours
Recipient has a positive T or B-cell cross match by investigational site's standard method of determination
Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:
* History of hypertension and a terminal serum creatinine \> 1.5 mg/dL
* Cerebrovascular accident as cause of death and a terminal serum creatinine \> 1.5 mg/dL
* History of hypertension and cerebrovascular accident as cause of death and a terminal serum creatinine \> 1.5 mg/dL
