Clinical Trial

Inhibiting Early Inflammation in Kidney Transplant Patients

Study Description

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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

Additional Information

Official Study Title

Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19)

Clinical Trial ID

NCT02495077

ParticipAid ID

oeE64a