During transplant surgery, there is a period of time when a donated kidney is removed from a
donor's body and stored until the time of the transplant surgery. The storage procedure
results in buildup of various proteins within the kidney that can injure the donated kidney
after it is transplanted. One of these proteins is tumor necrosis factor-alpha (TNF-alpha).
The purpose of this study is to evaluate whether taking infliximab, which blocks TNF-alpha,
just prior to transplant surgery along with usual transplant medicines will protect the
donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy
for a longer period of time.
Proportion of subjects with biopsy proven acute cellular rejection (BPAR)Proportion of subjects with biopsy proven acute cellular rejection (BPAR).
BANFF grades of first Acute Cellular Rejections (ACR).
Proportion of subjects with biopsy proven acute cellular rejection (BPAR) or borderline rejection.
Proportion of subjects with biopsy proven acute cellular rejection (BPAR) or borderline rejection
Proportion of subjects with biopsy proven acute antibody mediated rejection (AMR)
Proportion of subjects with biopsy proven acute antibody mediated rejection (AMR).
Proportion of subjects with biopsy proven acute antibody mediated rejection AMR or suspicious for AMR
Proportion of subjects with biopsy proven acute antibody mediated rejection AMR or suspicious for AMR.
BANFF grades of first AMR.
Proportion of subjects with BANFF chronicity scores > or equal 2.
Change in BANFF chronicity scores Change Between implantation and 24 month biopsies.
Change in eGFR between 3 months and 24 months
Change in eGFR between post-transplant nadir and 24 months
eGFR Values
Proportion of subjects with death or graft failure.
Proportion of subjects with only graft failure.
Proportion of subjects that required at least one dialysis treatment.
Number of dialysis sessions.
Duration of delayed graft function (DGF) defined from transplantation to the last required dialysis treatment.
The incidence of primary non-function (PNF), defined as for dialysis-dependency for more than 3 months.
Change from baseline (immediately after surgery) in serum creatinine and serum creatinine concentration.
Event (ACR, AMR, or hospitalization for infection and or malignancy)
Proportion of Slow Graft Function (SGF)
Ratio of Slow Graft Function (SGF)
Proportion of Slow Graft Function (SGF)
Proportion of Slow Graft Function (SGF)
Proportion of Slow Graft Function
Proportion of subjects with any infection requiring hospitalization or resulting in death.
Proportion of subjects with Mycobacterial or fungal infections
Proportion of subjects with CMV viremia require a change in immunosuppression or anti-viral treatment as per standard of care at the site
Proportion of subjects with BK viremia that require a change in immunosuppression or anti-viral treatment as per standard of care at the site.
Proportion of subjects with malignancy.
Proportion of subjects with impaired wound healing manifested by wound dehiscence, wound infection, or hernia at the site of the transplant incision
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.