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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
197
Day 0: Campath-1H 20 mg IV infusion over 3-6 hours Day 1: Campath-1H 20 mg IV infusion over 3-6 hours
Day 0: Tacrolimus will be given pre-operatively or immediately post transplant surgery. The recommended initial daily starting dose is 0,1 mg/kg/d orally (0,05 mg/kg/bid) to aim at a whole blood level of 8-12 ng/ml. till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months). Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months.
Day 0: Campath-1H 30 mg IV infusion over 3-6 hours Day 1: Campath-1H 30 mg IV infusion over 3-6 hours
University Hospital Innsbruck
Innsbruck, Tyrol, Austria
Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)
Time frame: Month 6
Biopsy proven acute rejection episodes 12 months after transplantation (Banff Classification)
Time frame: Year 1
Time to 1st biopsy proven acute rejection episode (Banff Cl.)
Time frame: Year 1
Patient and graft survival
Time frame: Year 1
Number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes
Time frame: Year 1
Treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection
Time frame: Year 1
Adverse events (e.g. infections, PTLD)
Time frame: Year 1
Creatinine clearance
Time frame: Year 1
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