BridgeMD
Compares treatment options for Kawasaki Disease
Official title 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
ClinicalTrials.gov ID: NCT04656184
What this study is testing
What is ANAKINRA?
ANAKINRA is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for kawasaki disease.
Also referred to as Kineret.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 17
You may be able to join if
- Children, male and female, from 3 months to \<18 years old
- Patient ≥ 5 kg
- Patient with KD according to the American Heart Association definition for complete or incomplete KD. (Fever ≥ 5 days (or at least 3 days if KD with...
- Patients who failed to respond to the standard therapy of KD, e.g. Persistence or recrudescence of fever ≥ 38°C, 48 hours after the infusion of 2g/kg...
- Patient, parents or legal guardian's written informed consent is required
You likely can't join if
- Preterm and neonates, pregnancy, pregnancy and breast feeding
- Suspicion of another diagnosis
- Patient with overt concomitant bacterial, viral or fungal infection
- Patient previously treated with steroids and/or another biotherapy
- Patient with increased risk of tuberculosis infection
- Recent tuberculosis infection or with active tuberculosis
See the full eligibility criteria
- Children, male and female, from 3 months to \<18 years old
- Patient ≥ 5 kg
- Patient with KD according to the American Heart Association definition for complete or incomplete KD. (Fever ≥ 5 days (or at least 3 days if KD with American Heart Association criteria since the third days of fever) and...
- Patients who failed to respond to the standard therapy of KD, e.g. Persistence or recrudescence of fever ≥ 38°C, 48 hours after the infusion of 2g/kg of IV Ig. Patients may be screened 24h after the end of the first...
- Patient, parents or legal guardian's written informed consent is required
- Patient with health insurance (SS or CMU).
- Efficient contraception for the duration of participation in the research for childbearing aged women
- Preterm and neonates, pregnancy, pregnancy and breast feeding
- Suspicion of another diagnosis
- Patient with overt concomitant bacterial, viral or fungal infection
- Patient previously treated with steroids and/or another biotherapy
- Patient with increased risk of tuberculosis infection
- Recent tuberculosis infection or with active tuberculosis
- Patient with any type of immunodeficiency or cancer
- Patients with severe renal impairment (CLcr \< 30 ml/minute)
- Patients with hepatic insufficiency
- Patients with neutropenia (ANC\<1.5 x109/l)
- Patients included in another treatment protocol
- Patient under the following treatments:
- Preventive Antipyretics (paracetamol, NSAIDs other than aspirin 30-50mg/kg given for purpose of KD inflammation), as long as the patient receives the study medication
- Immunosuppressive medications given in a period less than twice of their half-life prior the patient receives the study medication (systemic steroids, cyclosporine, tacrolimus, azathioprine, cyclophosphamide...
- Hypersensitivity to anakinra or excipients (citric acid, sodium chloride, disodium EDTA (Ethylene Diamine Tetra Acetic), polysorbate 80, sodium hydroxide, in water for injection)
- Hypersensitivity to IV Ig, or excipients (L-proline and water for injection), hypersensitivity to human normal immunoglobulin, in particular if the patient have anti-IgA antibodies (IgA: Immunoglobulin A)
- Patients with type I or II hyperprolinemia
- Live vaccines within 1 month prior to enrollment
- Hypersensitivity to anakinra or to immunoglobulins or to excipients of Kineret® or Privigen® or to E.coli proteins
- Contraindication for administration of anakinra or IVIG listed in the Summary of Products Characteristics (SmPC) of Kineret® and Privigen®
- Ongoing or recent use of any other medication Known inhibitors/inducers of cytochrome P450 as listed on the link below: http://medicine.iupui.edu/clinpharm/ddis/main-table
The study team makes the final eligibility decision.
Where it's taking place
- Le Kremlin-Bicêtre, Val De Marne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Kremlin-Bicêtre, Val De Marne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.