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ANACOMP. A RANDOMIZED PHASE III MULTICENTER 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
EU CTIS ID: 2024-516244-25-00
What this study is testing
To compare the efficacy of Anakinra (IL-1R1 receptor antagonist) with 2nd IVIG infusion, in second line, on fever in patients with KD, who failed to respond to one infusion of IVIG (standard treatment).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Children, male and female, from 12 months to <18 years old
- Patient ≥ 7,5 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 AHA criteria since the third days of fever) and ≥ 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, and bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral > 1.5 cm in diameter
- Patients not responding to standard therapy for KD, i.e, persistence or recrudescence of fever (≥38°C) during the 24 to 48 hours following the end of the IVIG infusion (2g/kg).Patients with fever lasting at least 5 days (≥5 days) and up to 11 days inclusive (≤ 11days).
- Patient, parents or legal guardian’s written informed consent is required
- Patient with health insurance (SS or CMU)
You likely can't join if
- Preterm and neonates, pregnancy and breast feeding
- Patients with neutropenia (ANC<1.5 x109/l)
- Patients included in another interventional protocol* Patient under the following treatments:
- 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, interferon, mycophenolate, other anti-IL-1, anti IL-6, anti CD20 and anti TNF), plasmapheresis)
- Hypersensitivity to anakinra (Kineret®) or excipients (citric acid, sodium chloride, disodium EDTA, polysorbate 80, sodium hydroxide, in water for injection)
- Hypersensitivity to IV Ig (Privigen®), or excipients (L-proline and water for injection), hypersensitivity to human normal immunoglobulin, in particular if the patient have anti-IgA antibodies
See the full eligibility criteria
Who can join
- Children, male and female, from 12 months to <18 years old
- Patient ≥ 7,5 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 AHA criteria since the third days of fever) and ≥ 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, and bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral > 1.5 cm in diameter
- Patients not responding to standard therapy for KD, i.e, persistence or recrudescence of fever (≥38°C) during the 24 to 48 hours following the end of the IVIG infusion (2g/kg).Patients with fever lasting at least 5 days (≥5 days) and up to 11 days inclusive (≤ 11days).
- 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
What rules you out
- Preterm and neonates, pregnancy and breast feeding
- Patients with neutropenia (ANC<1.5 x109/l)
- Patients included in another interventional protocol* Patient under the following treatments:
- 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, interferon, mycophenolate, other anti-IL-1, anti IL-6, anti CD20 and anti TNF), plasmapheresis)
- Hypersensitivity to anakinra (Kineret®) or excipients (citric acid, sodium chloride, disodium EDTA, polysorbate 80, sodium hydroxide, in water for injection)
- Hypersensitivity to IV Ig (Privigen®), or excipients (L-proline and water for injection), hypersensitivity to human normal immunoglobulin, in particular if the patient have anti-IgA antibodies
- 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
- 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 TB infection (e.g. close contact with a patient with tuberculosis, stay in a country with a high prevalence of tuberculosis for at least 3 months)
- Recent tuberculosis infection or with active TB (e.g abnormal chest X-ray: systematized lung disease, non-systematized lung disease, diffuse infiltrative images, pleural effusion, adenopathy, cardiomegaly).
- Patient with any type of immunodeficiency or cancer
- Patients with severe renal impairment (CLcr < 30 ml/minute)
- Patients with hepatic insufficiency
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.