Kawasaki DiseasePhase 3NCT02439996
Different Doses of IVIG for Kawasaki Disease
A Phase 3 study testing IVIG (1g/kg,once), IVIG (1g/kg,twice) and IVIG (2g/kg.once) in people with Kawasaki Disease, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- IVIG (1g/kg,once), IVIG (1g/kg,twice) and IVIG (2g/kg.once)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002.
- the patients aged from 1 months to 12 years old.
- All included patients required to sign an informed consent form.
- the patients didn't receive treatment before.
Who cannot join
- The patients with the application of hormone or other immunosuppressive agents;
- The patients didn't want to signed informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Different Doses of IVIG for Kawasaki Disease: a Multicentre, Prospective, Randomised Trial
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.
Read the detailed description
Kawasaki disease is an acute febrile illness recognized most often in young children. Coronary abnormality is the most serious complication preventable with intravenous immunoglobulin (IVIG) administration. Various treatment regimens of IVIG have been reported.The optimal administrative doses of IVIG deserves more observations.We will conduct a multicenter, randomized, prospective trial to determine the effect of different doses of IVIG (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease. The KD children will be randomly assigned to three groups and were given different IVIG regimen (1g/kg once, 1g/kg twice, 2g/kg once)as initial treatment. Patient age, gender, white blood cell count, hemoglobin, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), red blood cell specific volume (HCT) , serum albumin, the fever days,and the cost of hospital stay will be analyzed among the three groups. The primary outcome is the duration of fever subsided and the incidence of coronary artery lesions .
- Conditions
- Kawasaki Disease
- Being tested
- IVIG (1g/kg,once), IVIG (1g/kg,twice), IVIG (2g/kg.once)
- Keywords
- Kawasaki disease IVIG
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIG (1g/kg,once)Drug
Also called Asprin
Group C patients received IVIG 1g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h.
Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.
IVIG (1g/kg,twice)Drug
Also called Asprin
Group B patients received IVIG 1g/kg for 2 days continuously. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h.
Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.
IVIG (2g/kg.once)Drug
Also called Asprin
Group A patients received IVIG 2g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h.
Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.
| Study group | Role | What they receive |
|---|---|---|
| IVIG(1g/kg,once) | Experimental | The KD children will be randomly assigned to three groups. The patients in group C will receive IVIG 1g/kg once. Receives: Drug: IVIG (1g/kg,once) |
| IVIG(1g/kg,twice) | Experimental | The KD children will be randomly assigned to three groups. The patients in group B will receive IVIG 1g/kg for 2 days continuousl. Receives: Drug: IVIG (1g/kg,twice) |
| IVIG(2g/kg.once) | Active comparator | The KD children will be randomly assigned to three groups. The patients in group A will receive IVIG 2g/kg once. Receives: Drug: IVIG (2g/kg.once) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of fever subsided to normal after initial IVIG finished
Hours of fever subsided to normal after initial IVIG finished
Measured: 36 hours after IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography
Measured: start from IVIG finished, ended by the end of 2 weeks
Secondary outcomes (6)
incidence of coronary artery lesions(CAL) after IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography
Measured: start from IVIG finished, ended by the end of 1 month
incidence of coronary artery lesions(CAL) after IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography
Measured: start from IVIG finished, ended by the end of 3 month
incidence of coronary artery lesions(CAL) after IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography and coronary atery angiogram
Measured: start from IVIG finished, ended by the end of 6 month
Total dose of immunoglobin used for every patient
Total dose of immunoglobin used for every patient
Measured: estimated about up to 10 days, start from admission,ended by discharge
total medical cost for KD treatment during hospital stay
record the hospital duration of every patient and the medical expenses for KD
Measured: estimated about up to 10 days, start from admission,ended by discharge
total frequency (%) of severe adverse events
Severe adverse events included death, infection or exacerbation, heart failure, allergic reaction, etc
Measured: estimated about up to 10 days, start from admission,ended by discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Medical Center, Shanghai Children's Hospital
- Responsible party
- Principal investigator, Guoying huang, Children's Hospital of Fudan University
- Investigators
- Guoying Huang, PHD, Study chair, Children Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439996
- Sponsor's protocol ID
- KD(2015-2016)
- Status last verified
- May 2018
- First submitted
- 7 May 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
He L, Liu F, Yan W, Huang M, Huang M, Xie L, Guo Y, Xu X, Chu C, Wu L, Liang X, Sun S, Wang F, Zhao L, Zhao Q, Ma X, Xie L, Huang G. Randomized trial of different initial intravenous immunoglobulin regimens in Kawasaki disease. Pediatr Int. 2021 Jul;63(7):757-763. doi: 10.1111/ped.14656. Epub 2021 Jun 16.
PubMed 33600060
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Doses of IVIG for Kawasaki Disease: a Multicentre, Prospective, Randomised Trial
- ClinicalTrials.gov ID
- NCT02439996
- Acronym / sponsor ID
- KD(2015-2016)
- Conditions
- Kawasaki Disease
- Keywords
- Kawasaki disease IVIG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Children's Medical Center, Shanghai Children's Hospital
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Kawasaki disease is an acute febrile illness recognized most often in young children. Coronary abnormality is the most serious complication preventable with intravenous immunoglobulin (IVIG) administration. Various treatment regimens of IVIG have been reported.The optimal administrative doses of IVIG deserves more observations.We will conduct a multicenter, randomized, prospective trial to determine the effect of different doses of IVIG (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease. The KD children will be randomly assigned to three groups and were given different IVIG regimen (1g/kg once, 1g/kg twice, 2g/kg once)as initial treatment. Patient age, gender, white blood cell count, hemoglobin, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), red blood cell specific volume (HCT) , serum albumin, the fever days,and the cost of hospital stay will be analyzed among the three groups. The primary outcome is the duration of fever subsided and the incidence of coronary artery lesions .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IVIG(1g/kg,once) | Experimental | Drug: IVIG (1g/kg,once)The KD children will be randomly assigned to three groups. The patients in group C will receive IVIG 1g/kg once. |
| IVIG(1g/kg,twice) | Experimental | Drug: IVIG (1g/kg,twice)The KD children will be randomly assigned to three groups. The patients in group B will receive IVIG 1g/kg for 2 days continuousl. |
| IVIG(2g/kg.once) | Active comparator | Drug: IVIG (2g/kg.once)The KD children will be randomly assigned to three groups. The patients in group A will receive IVIG 2g/kg once. |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002.
- the patients aged from 1 months to 12 years old.
- All included patients required to sign an informed consent form.
- the patients didn't receive treatment before.
Key exclusion criteria (2 listed)
- The patients with the application of hormone or other immunosuppressive agents;
- The patients didn't want to signed informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIG (1g/kg,once)Also: AsprinGroup C patients received IVIG 1g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once. | Drug | IVIG(1g/kg,once) |
| IVIG (1g/kg,twice)Also: AsprinGroup B patients received IVIG 1g/kg for 2 days continuously. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once. | Drug | IVIG(1g/kg,twice) |
| IVIG (2g/kg.once)Also: AsprinGroup A patients received IVIG 2g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once. | Drug | IVIG(2g/kg.once) |
Primary outcome
Duration of fever subsided to normal after initial IVIG finished
Time frame: 36 hours after IVIG finished
Hours of fever subsided to normal after initial IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished
Time frame: start from IVIG finished, ended by the end of 2 weeks
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography
6 secondary outcomes
incidence of coronary artery lesions(CAL) after IVIG finished
Time frame: start from IVIG finished, ended by the end of 1 month
incidence of coronary artery lesions(CAL) after IVIG finished
Time frame: start from IVIG finished, ended by the end of 3 month
incidence of coronary artery lesions(CAL) after IVIG finished
Time frame: start from IVIG finished, ended by the end of 6 month
Total dose of immunoglobin used for every patient
Time frame: estimated about up to 10 days, start from admission,ended by discharge
total medical cost for KD treatment during hospital stay
Time frame: estimated about up to 10 days, start from admission,ended by discharge
total frequency (%) of severe adverse events
Time frame: estimated about up to 10 days, start from admission,ended by discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 33600060He L, Liu F, Yan W, Huang M, Huang M, Xie L, Guo Y, Xu X, Chu C, Wu L, Liang X, Sun S, Wang F, Zhao L, Zhao Q, Ma X, Xie L, Huang G. Randomized trial of different initial intravenous immunoglobulin regimens in Kawasaki disease. Pediatr Int. 2021 Jul;63(7):757-763. doi: 10.1111/ped.14656. Epub 2021 Jun 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoying Huang, PHD study chair
Children Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IVIG (1g/kg,once), IVIG (1g/kg,twice) and IVIG (2g/kg.once) in people with Kawasaki Disease, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of fever subsided to normal after initial IVIG finished (time frame: 36 hours after IVIG finished). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02439996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.