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About
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.
Enrollment
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Inclusion criteria
Recipients, who are at least 18 years or older and have a high immunological risk defined by:
The presence of at least one donor-specific antibody (class I and/or II) detected and specified by flow-technology (FlowPRA and single antigen beads), which are
Patient receives a renal allograft only.
Female patients of child bearing age agree to maintain effective birth control practice during the study.
Patient has been fully informed and has given written or independent person witnessed oral informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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