An open, multicenter, randomised, parallel group pilot study to investigate two different polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantation. This non-inferiority trial shall demonstrate that ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d
Day 0-3: 1.5 mg/kg bw/d
University Hospital Basel, Transplantation Immunology and Nephrology
Basel, Switzerland
Adverse events
Time frame: Daily
Rejection
Time frame: Daily
Graft function
Time frame: Daily
Patient survival
Time frame: Daily
Graft survival
Time frame: Daily
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