Clinical Trials for Kawasaki Disease

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Kawasaki Disease from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 11
• Active, not recruiting: 1
• Completed: 20
• Other: 18

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT01793168 — Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups,…

NCT04278404 — Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their tre…

NCT06775457 — Genome Analysis of Human Endogenous Retroviruses (HERVs)(COVID19)

Human Endogenous Retroviruses (HERVs) are ancient sequences that became integrated into our DNA during evolutionary processes.

The significance of their presence in DNA is still being studied, but HERVs appear to be involved in the regulation of the immune response.

The gut microbiota is the set of microorganisms that physiologically colonize the gastrointestinal tract. Progressively increasi…

NCT06305611 — European and North Indian Cohort of KaWasaki dIsease

Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unf…

NCT06993636 — Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and …

NCT04656184 — A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment

Kawasaki disease (KD) is the most frequent vasculitis in younger children <5years, and the first cause of acquired ischemic myocardiopathy in childhood. Exceptionally, KD may cause early death during the acute phase by myocardial infarction, but may compromise the long-term cardiovascular outcome by accelerating atherosclerotic disease.

The incidence of KD is high in far-Eastern countries and…

NCT06978439 — Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease

Based on a population pharmacokinetic model-based dose optimization study, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after Kawasaki disease was proposed. This single-center, single-arm, pilot study aims to evaluate the feasibility of the 15 mg-equivalent dosing regimen within a limited sample size.

Patients will b…

NCT07291245 — Kawasaki MATCH Trial

Evaluating the impact of a machine-learning clinical decision support tool on provider practice when evaluating febrile patients with Kawasaki Disease (KD) and non-KD illnesses.

NCT07086989 — Cardiovascular Risk in Children With Chronic Conditions Study

Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels. Although experts recognize this elevated risk and recommend close monitoring and early intervention, the underlying mechanisms driving this phenomenon remain poorly understood. At present, no effective inte…

NCT05643651 — Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease

Based on population pharmacokinetic model-based simulation, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after acute Kawasaki disease was proposed. This exploratory trial aims to evaluate the feasibility, safety and effectiveness of rivaroxaban compared to warfarin for thromboprophylaxis in children aged over 2 years …

NCT07530640 — Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities

The goal of this observational study is to learn about the safety and effects of atorvastatin in treatment of Chinese Kawasaki disease (KD) children complicated with coronary artery abnormalities (CAA) in acute phase. The main questions it aims to answer are: Is atorvastatin safe in Chinese children of acute KD? Does atorvastatin contribute to control the acute inflammation in KD and improve th…

Active, Not Recruiting

NCT01917721 — Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease

Kawasaki disease (KD) affects infants and young children causing inflammation of the skin and blood vessels including the coronary arteries of the heart. Despite the currently available therapy, about one third of children develop enlargement of the coronary arteries that can lead to serious complications such as coronary artery stenosis, heart attack and even death.

Kawasaki disease is the mo…

Not Yet Recruiting

NCT06697431 — Non Inferiority KawasakI Trial With Anakinra

This is a multicenter, open-label, randomized, controlled, interventional trial followed by a long-term observational extension period in patients with Kawasaki Disease (KD) to be treated eitherwith endovenous Immunoglobulins (IVIG-standard treatment) versus anakinra

Aim of the study: to demonstrate that anakinra is non-inferior to IVIG in KD, in terms of fever control in the acute phase and d…

NCT07491926 — MASKd: a Study on Kawasaki Disease (KD) Complicated by Macrophage Activation Syndrome (MAS)

Kawasaki Disease (KD) is one of the most common vasculitides in childhood and represents a leading cause of acquired heart disease in developed countries. Macrophage Activation Syndrome (MAS) is a potentially life threatening hyperinflammatory condition belonging to the spectrum of hemophagocytic lymphohistiocytosis (HLH), and it can complicate various rheumatologic diseases. Awareness of MAS i…

NCT07405658 — Clinical Study on an Artificial Intelligence-Assisted Chest Radiograph Model Based on Big Data and Deep Learning for Early Detection of Kawasaki Disease

The goal of this observational study is to develop an AI-based early warning system for Kawasaki Disease (KD) using chest X-rays (CXR) in children diagnosed with Kawasaki Disease. The main question[s] it aims to answer are:

1. Can AI modeling of CXR features help identify high-risk KD patients earlier than current diagnostic methods?
2. Can the AI system predict the optimal IVIG treatment wi…

NCT07686770 — Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease

This study evaluates the efficacy and safety of the addition of Firsekibart to conventional initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in children with Acute Kawasaki Disease (KD) .

Enrolling by Invitation

NCT06641817 — The Value of Cardiovascular Imaging in Kawasaki Disease

The goal of this observational study is to assess the cardiovascular injury of Kawasaki disease with multi-modal imaging combined with clinical data.

During their disease progress, participants will undergo cardiovascular magnetic resonance, echocardiography, electrocardiography, laboratory tests, and genetic tests when hospitalization and follow-up, and the baseline data will be collected at …

NCT06641843 — Magnetic Resonance Myocardial Stress Perfusion in Pediatric Patients with Cardiovascular Disease

the goal of this observational study is to evaluate myocardial ischemia and myocardial microcirculation dysfunction in children with cardiovascular disease by myocardial stress perfusion imaging.

During their disease progress, participants will undergo myocardial stress perfusion, laboratory tests when hospitalization and follow-up, and the baseline data will be collected in the admission. all…

Completed Trials

NCT00157079 — Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.

NCT00162032 — A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease

Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.

NCT00841789 — A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease

The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD

NCT00861848 — Real Time Myocardial Contrast Echocardiography and Dobutamine Stress Perfusion Magnetic Resonance Imaging

The present study is designed to:

1. investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 12-50 with congenital and acquired congenital heart disease
2. compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow reserve and ventricular wall motion
3. assess regional myocardial mechanics using myocardial …

NCT01440075 — Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease

Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism.

It has been reported worldwide, but it is ten times more common in Asian population. The annual incidence in children under 5 years in Europe is estimated at 8 to 100000. It is the second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of cases between 1 and 5 years, with a…

NCT01596335 — Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease

The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The pharmacokinetics of TA-650 is also examined.

NCT01431105 — Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although investigators can identify children with KD that have these coronary artery abn…

NCT02439996 — Different Doses of IVIG for Kawasaki Disease

The objective of this study is to investigate the effect of different doses of intravenous immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a multicentre, prospective,randomised trial.

NCT02179853 — Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that may lead to complications later in life, including heart attack. Although the investigators can identify children with KD that have these coronary artery a…

NCT02390596 — Anakinra and Kawasaki Disease

The study is designed to assess the efficacy and safety of anakinra, an interleukin 1 receptor antagonist, in patients with Kawasaki disease who failed to respond to standard treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.

NCT03902262 — Acute Abdomen in Kawasaki Disease

Clinical and histopathological description of three cases of Kawasaki disease with acute abdomen.

NCT03065244 — KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)

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 arter…

NCT03880929 — Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017

To investigate the epidemiologic features of Kawasaki disease (KD) in Shanghai from 2013 through 2017 and identify the risk factors for coronary artery lesions.

NCT03750123 — Cardiovascular Status of Children 5 Years After Kawasaki Disease

The aim of present study is to determine cardiovascular status of children who had KD in past and to identify possible biochemical markers of cardiovascular damage in those patients.

In this cross-sectional study children with history of KD will be examined 5 years after receiving intravenous immunoglobulin treatment (IVIG) and compared to healthy controls in terms of: serum levels of endothel…

NCT04003844 — Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease

The purpose of this study is to evaluate the efficacy and safety of high-dose human Immunoglobulin G Intravenous (IGIV) 10% in subjects with Kawasaki diseases (KD).

NCT04747847 — Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although we can identify children with KD that have these coronary artery abnormalities,…

NCT03915795 — Statins Study in Kawasaki Disease Children With Coronary Artery Abnormalities

The aim of this study is to investigate the effects of statins on chronic inflammation, coronary artery abnormalities and clinical cardiac events in long-term KD children complicated with severe coronary artery abnormalities, and the feasibility and safety of statins in treatment of KD children.

NCT04078568 — Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease

This study evaluates the efficacy of the addition of prednisolone to conventional initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in reducing coronary artery lesion in children with Kawasaki disease (KD) .

NCT06309303 — Kawasaki Disease During the COVID-19 Epidemic

Northern Italy is the second region hit by the SARS-COV2 infection worldwide. Data on COVID-19 clinical presentation in children is still scarce, but fewer rate of infection and milder disease seem typical of this age group. In the last three weeks it has been reported an abnormal number of critically ill patients with clinical characteristics consistent with Kawasaki Shock Syndrome (KSS). The …

NCT04538495 — Characterization of Multisystem Inflammatory Syndrome in Children (MIS-C) and Its Relationship to Kawasaki Disease

Beginning in mid-March 2020, pediatricians in communities in Western Europe, the UK, and the Eastern U.S. that had been severely affected by the Covid-19 pandemic noted an increased number of children presenting with fever and evidence of severe inflammation who required admission to intensive care. The syndrome was branded by the CDC in the U.S. as Multisystem Inflammatory Syndrome in Children…

Other (Unknown)

NCT03861130 — Genetic Determinants of Kawasaki Disease

Kawasaki disease (KD) is an acute self-limited vasculitis of infancy and early childhood. Most patients recover without sequelae although the inflammatory process causes permanent damage to the coronary arteries in 20-25% of untreated children. An infectious aetiology is suspected, but the causative agent has not been identified. The investigators aim to identify the genes underlying both susce…

NCT03200561 — A Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study)

Background:

Kawasaki disease (KD), most popular acquired heart disease in childhood, is characterized by diffuse vasculitis, especially on the middle-sized muscular arteries. IVIG and aspirin are currently standard treatment. However, 10-15% of KD patients have poor response to such treatment and suffer from higher risk of coronary involvement. Recently, combination of prednisolone and IVIG ha…

NCT02951234 — A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease

Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The…

Other (Withdrawn)

NCT02980263 — Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease

The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or refractory patients diagnosed with active Kawasaki disease, administration of canakinumab controls fever and acute phase reactants.

NCT04509219 — Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease

In this study, the investigator plan to prescribe Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery lesions or aneurysm formation beyond acute stage to investigate the role for vasculitis of KD or regression of dilatation.

NCT04455347 — Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked

To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRI and/or CT scan including cardiac functional evaluation and myocardial tissue characterization of COVID_19 related disease in pediatric patients with cardiac involvement.

NCT04535518 — Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease

This study evaluates the efficacy of the addition of infliximab to conventional initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in early regression of coronary artery lesion in patients with Kawasaki disease (KD).

NCT04777422 — Defibrotide in Children With High Risk Kawasaki Disease

This study evaluates the safety of defibrotide with IVIG in children with high risk Kawasaki disease.

NCT05347901 — Clinical Precise Diagnosis and Treatment in the Kawasaki Disease

The purpose of this project is to explore the differential gene expression profile of Kawasaki disease, and will explore the diagnosis and treatment targets related to coronary artery injury or kawasaki disease susceptibility, vascular damage, IVIG (intravenous immunoglobulin) treatment resistance, incomplete Kawasaki disease, etc.

NCT05434611 — Role of Calcium Binding Protein S100A12 in Diagnosis and Prognosis of Kawasaki Disease

Recent studies showed that the value of c100A12 increased in children with Kawasaki disease, and decreased rapidly after treatment with gamma globulin. In kawasaki disease with coronary artery dilatation, S100A12 levels are elevated in the acute phase of Kawasaki disease and continue for some time in the convalescence phase before gradually decreasing. However, the number of patients included i…

NCT05091229 — A Blood Test to Diagnose Kawasaki Disease

A case-control cohort study is being conducted to develop and validate the performance of a whole blood gene expression qPCR test to distinguish KD from other febrile conditions by collecting whole blood sample from KD patients in the first 7 days of illness and from febrile controls immediately after presentation and before clinical diagnosis is confirmed.

NCT05911386 — Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases

Acquired inflammatory or infectious cardiac diseases, in pediatrics, include Kawasaki disease, myocarditis, and Covid-19-related Pediatric Multisystemic Inflammatory Syndrome (PIMS).

These 3 inflammatory cardiac diseases have clinical, biological, and echographic similarities and differences. Nevertheless their modalities of monitoring, management and evolution are different. The investigators…