“Effects of Inhibiting Early Inflammation in Kidney Transplant Patients”
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 tumor necrosis factor alpha (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.
Biological - Infliximab
A single dose, of 3mg/kg infusion
Drug - Methylprednisolone
500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion
Drug - Mycophenolate Mofetil
Administered at a target dose of 2000mg daily, as tolerated, until study closure
Drug - Tacrolimus
Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure
Biological - Thymoglobulin®
Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated
Drug - Acetaminophen
30 to 60 minutes prior to the start of the infusion Tylenol, 600 to 1000mg by mouth or Suppository form
Drug - Loratadine
30 to 60 minutes prior to the start of the infusion Claritin (Loratadine) 10mg by mouth or Benadryl (Diphenhydramine) 25 or 50 mg by mouth
Biological - Placebo for Infliximab
A single dose is volume matched to Infliximab (250mL) infusion
Drug - Prednisone
Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.
Drug - Diphenhydramine
30 to 60 minutes prior to the start of the infusion Claritin (Loratadine) 10mg by mouth or Benadryl (Diphenhydramine) 25 or 50 mg by mouth
Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19)
NCT02495077
oeE64a