A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Alefacept; Antibodies, Monoclonal; Basiliximab; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• 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

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:

• 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