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Effects of Inhibiting Early Inflammation in Kidney Transplant Patients
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Official title: Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
290
Start Date
2015-11-02
Completion Date
2021-07-23
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
Infliximab
A single dose, of 3mg/kg infusion
Methylprednisolone
500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion
Mycophenolate Mofetil
Administered at a target dose of 2000mg daily, as tolerated, until study closure
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
Thymoglobulin®
Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated
Acetaminophen
30 to 60 minutes prior to the start of the infusion * Tylenol, 600 to 1000mg by mouth or * Suppository form
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
Placebo for Infliximab
A single dose is volume matched to Infliximab (250mL) infusion
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.
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
Locations (15)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Mount Sinai Medical Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
University of Wisconsin
Madison, Wisconsin, United States
University of Manitoba
Winnipeg, Manitoba, Canada
Toronto General Hospital
Toronto, Ontario, Canada