Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is more effective in the prevention of renal graft rejection (considering an acute rejection rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Claudia Bösmüller
• Collaborator: Astellas Pharma GmbH
• Treatments: Alemtuzumab; Methylprednisolone; Tacrolimus

Criteria

Inclusion Criteria:

• age 18-65

• endstage renal failure with no previous renal transplantation

• cadaveric donor

• written informed consent

Exclusion Criteria:

• pregnant or nursing women

• multi-organ transplant recipients

• live donor recipients

• re-transplants

• panel reactive antibodies (PRA) > 25%

• previous treatment with Campath-1H

• use of other investigational agents within 6 weeks

• active systemic infection

• HIV positive patient or donor

• positive lymphocyte cytotoxicity cross-match between recipient serum and donor cells

• past history of anaphylaxis following exposure to humanized monoclonal antibodies