A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients
A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.
Inclusion Criteria:
Exclusion Criteria:
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:
San Diego, California 92123, United States