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Completed Phase 3 Interventional Results available

KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)

ClinicalTrials.gov ID: NCT03065244

Public ClinicalTrials.gov record NCT03065244. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 7:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Kawasaki disease (KD) is a self-limited illness that affects the heart blood vessels (coronary arteries) of infants and children and is now the most common cause of acquired heart disease in children. A mixture of proteins from human blood (Intravenous immunoglobulin, IVIG) is a treatment that reduces the rate of the major complication of the disease: a bulging of the wall of the coronary arteries called an aneurysm. However, 10-20% of children are resistant to this treatment and the fever returns. These children have the highest rates of aneurysm formation and thus should be treated aggressively. Unfortunately, there are no guidelines for the best secondary treatment for these resistant patients because the problem has never been adequately studied. Most physicians choose either a second infusion of IVIG or an engineered antibody called infliximab that inactivates a molecule that promotes inflammation. This trial will randomize (assign by chance like the flip of a coin) IVIG-resistant patients to receive either a second IVIG infusion or infliximab and the response to treatment will be compared to learn which treatment stops the fever the fastest. In addition, parents and caregivers will provide observations about their child's response to the different treatments.

Study identification

NCT ID
NCT03065244
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
105 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Up to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 16, 2017
Primary completion
Aug 30, 2020
Completion
Nov 1, 2020
Last update posted
Dec 2, 2021

2017 – 2020

United States locations

U.S. sites
29
U.S. states
20
U.S. cities
27
Facility City State ZIP Site status
UAB Children's of Alabama Birmingham Alabama 35233
Arkansas Children's Hospital Little Rock Arkansas 72202
University of California San Diego La Jolla California 92093
Memorial Care Long Beach California 90806
Children's Hospital Los Angeles Los Angeles California 90027
David Geffen School of Medicine at UCLA Los Angeles California 90095
Harbor-UCLA Medical Center Los Angeles California 90502
UCSF Benioff Children's Hospital-Oakland Oakland California 94609
Children's Hospital of Orange County Orange California 92868
UCSF Benioff Children's Hospital-San Francisco San Francisco California 94920
Cedar-Sinai Medical Center West Hollywood California 94305
Children's Hospital of Colorado Aurora Colorado 80045
Children's National Health SYstem Washington D.C. District of Columbia 20010
Children's Healthcare of Atlanta Atlanta Georgia 30322
Comer Children's Hospital Chicago Illinois 60637
Riley Children's Health Indiana University School of Medicine Indianapolis Indiana 46202
Boston Children's hospital Boston Massachusetts 02115
Children's Hospital of Michigan Detroit Michigan 48201
Children's Mercy Kansas Ciry Kansas City Missouri 64108
University of Nebraska Medical Center Omaha Nebraska 68198
Maria Fareri Children's Hospital Valhalla New York 10595
Nationwide Children's Hospital Columbus Ohio 43205
UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224
University of South Dakota Sanford School of Medicine Sioux Falls South Dakota 57105
Vanderbilt University Medical Center Nashville Tennessee 37232
Children's Medical Center of Dallas Dallas Texas 75235
Texas Children's Hospital Houston Texas 77030
Primary Care University of Utah Salt Lake City Utah 84113
Seattle Children's Seattle Washington 98101

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03065244, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 2, 2021 · Synced Sep 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03065244 live on ClinicalTrials.gov.

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