To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.
To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in de novo 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) and renal function
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
280
Intravenous (IV)
Unnamed facility
Beijing, China
Unnamed facility
Changchun, China
Unnamed facility
Chengdu, China
Unnamed facility
Guangzhou, China
efficacy failure
Efficacy failure is defined as any of the following events: * patient's death, * graft loss, * acute rejection, * and/or lost to follow-up.
Time frame: 12 months post-transplant
Incidence of acute rejection
Time frame: 6 and 12 months
Incidence of DGF
DGF = delayed graft function
Time frame: 6 and 12 months
Incidence of patient survival
Time frame: 6 and 12 months
Incidence of graft survival
Time frame: 6 and 12 months
Renal function: serum creatinine/eGFR
Time frame: 1, 3, 6 and 12 months
incidence and severity of AEs
Time frame: 6 months and 12 months
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Unnamed facility
Hangzhou, China
Unnamed facility
Jinan, China
Unnamed facility
Nanjing, China
Unnamed facility
Shanghai, China
Unnamed facility
Shenyang, China
Unnamed facility
Tianjin, China
...and 4 more locations