Clinical trialNCT02495077CompletedPhase 2Interventional

Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment290Kidney Transplant

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Donald E Hricik, MD
University Hospitals of Cleveland, Division of Nephrology & Hypertension
Study Chair
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Peter S. Heeger, MD
Icahn School of Medicine at Mount Sinai, Recanati Miller Transplant Institute
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

University of Manitoba
Winnipeg, Manitoba, Canada
Toronto General Hospital
Toronto, Ontario, Canada

United States

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
Johns Hopkins University
Baltimore, Maryland, United States
University of Maryland
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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Acetaminophen →Diphenhydramine →Infliximab →LoratadineMethylprednisolone →Mycophenolate mofetil →Placebo for InfliximabPrednisone →Tacrolimus →Thymoglobulin®

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Nov 2015
Primary completion: 23 Jul 2021
Completion: 23 Jul 2021
Last update posted: 16 Aug 2022
Registered enrollment: 290
Registry id: NCT02495077

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.