The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation.
This pilot study is designed to show differences in efficacy, safety and cost between the two regimens. Its main purpose is to provide information, if calcineurin free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients. Furthermore, by investigating the side effects in both arms it will be possible to decide, if the absence of calcineurin inhibition and lack of nephrotoxicity will outweigh the adverse effects of Rapamycin. With the obtained information it will be possible to plan a larger trial, which is warranted to compare the mentioned treatment regimens in more detail.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
127
Loading dose 30 mg for three days, trough level of 10-20 ng/ml month 1-3, 8-15 ng/ml month 4 - 6
Loading dose of 300 mg for three days, trough levels 250-300 ng/ml months 1-3, 150-250 ng/ml months 4 to 6
0.5 mg/kg, tapering every two weeks until 0.1 mg/kg
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
Basel, Switzerland
Plasma Creatinine
Time frame: 6 months
Graft survival
Time frame: 6 months
Patient survival
Time frame: 6 months
Incidence of first acute rejections and number of total rejections
Time frame: 6 months
Total number of anti-rejection treatments
Time frame: 6 months
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2 x 1000mg, through level above 2ug/ml
protocol kidney biopsies at month one and three