Efficacy and Safety of Alemtuzumab for prevention of graft rejection and preservation of renal function in patients receiving Kidney Transplant

Exclusion Criteria17

• Pregnant or nursing or woman of child bearing potential unwilling/unable to practice an acceptable form of birth control
• Major systemic or other illness that would, in the opinion of the investigator, interfere with the patient’s ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
• Multi-organ transplant recipient
• Prior renal transplants
• Previous treatment with alemtuzumab
• Patient requiring anti-lymphocyte preparations/interleukin receptor antibody preparations for induction therapy
• Patient requiring cyclosporine, mycophenolic acid analogues or Mammalian Target of Rapamycin (mTOR) inhibitors as initial therapy
• Use of other investigational agents within 6 weeks prior to transplantation
• Active systemic infection
• Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or anti-hepatitis C antibody positive (if Hepatitis C Virus Polymerase Chain Reaction (HCV PCR) unavailable) or Hepatitis C Virus Polymerase Chain Reaction (HCV PCR) positive
• Positive T lymphocyte cytotoxicity cross-match between recipient serum and donor cells
• Autoimmune hemolytic anemia
• Past history of anaphylaxis following exposure to humanised monoclonal antibodies
• Panel Reactive Antibodies (PRA) equal or greater than 50%
• Inability to undergo transplant biopsy, including patient who will require anticoagulation
• Cold ischemia time greater than 24 hours
• Patient whose graft function or perfusion cannot be demonstrated within 5 hours post-anastomosis.