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).

Condition	Intervention	Phase
Kidney Transplantation	Drug: Alemtuzumab	Phase III

Further Study Details: 

Primary Outcomes: biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)
Secondary Outcomes: - biopsy proven acute rejection episodes 12 months after Transplantation (Banff Cl.); - time to 1st biopsy proven acute rejection episode (Banff Cl.); - patient and graft survival; - number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes; - treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection; - adverse events (e.g. infections, PTLD); - creatinine clearance
Expected Total Enrollment:  130

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 observative 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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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

Austria
      Medical University for Surgery and Transplantation, Innsbruck,  6020,  Austria

Study chairs or principal investigators

Raimund Margreiter, Prof. Dr.,  Principal Investigator,  Medical University for Surgery and Transplantation, Innsbruck   

Study ID Numbers:  TaCam 06_MC; DE-02-RG-121/Margreiter
Last Updated:  September 6, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00147381
Health Authority: Austria: Federal Ministry for Health and Women
ClinicalTrials.gov processed this record on 2005-09-13