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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
45
Induction therapy regimen in simultaneous pancreas kidney transplantation
Induction therapy regimen in simultaneous pancreas kidney transplantation
Tianjin First central hospital
Tianjin, China
Incidence and severity of adverse event
Incidence of patient's death,graft loss,acute rejection
Time frame: up to 3 months post-transplantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.