Diabetes Mellitus Clinical Trial
Official title:
Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients: Single-centre, Prospective, Observational Study
A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.
Polyclonal antibody mainly contains Antit-Tlymphocyte globulins(Grafalon) and Anti-thymocyte
globulins(ATG). To investigate the efficacy and safety of polyclonal antibodies induction
regimen using Grafalon compared with ATG in de novo simultaneous pancreas kidney transplant
recipients. The primary analysis of this study is to demonstrate the non-inferiority of the
two regimens with regard to efficacy, defined as failure rate.
The secondary objective of the study is the assessment of safety and further efficacy
parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed
graft function), pancreas function and renal function
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