At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19)
In Brief
A Phase 2 clinical trial evaluating Infliximab, Methylprednisolone, and 8 other interventions for Kidney Transplant. Completed, enrolled 290 participants across 15 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
A single dose, of 3mg/kg infusion
500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion
Administered at a target dose of 2000mg daily, as tolerated, until study closure
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
Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated
30 to 60 minutes prior to the start of the infusion * Tylenol, 600 to 1000mg by mouth or * Suppository form
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
A single dose is volume matched to Infliximab (250mL) infusion
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.
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