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

Effectiveness and Safety of Campath-1H as an Induction Agent in Combination With Tacrolimus Monotherapy for Prevention of Graft Rejection Compared to Tacrolimus in Combination With MMF and Steroids in Cadaveric Kidney Transplantation

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).

Major advances in immunosuppressive therapy have resulted in long-term graft survival by the use of various drug combinations.However, these combinations carry the risk of e.g. infection, malignancy, renal damage, hypertension, diabetes, hyperlipidemia, hirsutism, cushingoid facial appearance and bone necrosis.Therefore one of the major goals should be to reduce immunosuppression without increasing risk of rejections.

Based on good results of a pilot study (not a single acute rejection episode during the 18-20 months observation period despite low level of Tacrolimus and absence of steroids) this randomised trial was designed to further evaluate the safety and efficacy of Campath-1H.

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