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COMPLETED
NCT02495077
PHASE2

Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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

Interventions

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

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