Comparing Anakinra and IVIG for Kawasaki Disease Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness and safety of Anakinra, an interleukin-1 receptor antagonist, compared to a second infusion of intravenous immunoglobulin (IVIG) in children with Kawasaki Disease who did not respond to initial IVIG treatment. It is a multicentric, randomized, controlled trial designed to assess whether Anakinra can reduce fever and improve other clinical outcomes within two days of treatment. The study will measure various secondary endpoints, including disease activity, coronary lesions, and inflammation markers. The trial aims to provide insights into alternative treatment options for this serious condition.

Why it matters

Who can join: the full rules

Inclusion 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 ≥ 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 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 infusion if they remain febrile 24h after the end of the first infusion.
* 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

Exclusion Criteria:

* 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 interventional 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, interferon, mycophenolate, other anti-IL-1, anti IL-6, anti CD20 and anti TNF (Tumor Necrosis Factor)), plasmapheresis)
* 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

Where it's running

• CHU de Bicêtre
  Le Kremlin-Bicêtre, Val De Marne, France Recruiting

Study contacts

• Study coordinator: Isabelle Koné-Paut, Pr
• Email: isabelle.kone-paut@aphp.fr
• Phone: 00 33 1 45 21 32 46

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Atorvastatin in Chinese children with Kawasaki disease and coronary artery abnormalities

  This phase 3 study tests whether atorvastatin is safe and helpful for children with Kawasaki disease who have coronary artery abnormalities.

  Recruiting Phase 3 Children's Hospital of Fudan University · Shanghai · NCT07530640

• Kawasaki MATCH decision support for suspected Kawasaki disease

  This study will test a machine-learning tool called Kawasaki MATCH to help providers decide if febrile children might have Kawasaki disease.

  Recruiting University of California, San Diego · San Diego, California · NCT07291245

• Cardiovascular health in children and young adults with chronic conditions

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  Recruiting Semmelweis University · Budapest and 2 other locations · NCT07086989

• Analyzing Rivaroxaban in Chinese Children with Kawasaki Disease

  This study is testing how well the blood thinner rivaroxaban works in children with Kawasaki disease who have serious heart problems.

  Recruiting Children's Hospital of Fudan University · Shanghai, Shanghai Municipality · NCT06993636

• Optimizing Rivaroxaban Dosing for Children with Giant Coronary Aneurysms After Kawasaki Disease

  This study is testing a new way to dose a blood thinner called rivaroxaban for Chinese children with giant coronary aneurysms after Kawasaki disease to see if it helps prevent heart problems.

  Recruiting Phase 4 Children's Hospital of Fudan University · Shanghai, Shanghai Municipality · NCT06978439

• Observing Kawasaki disease in European and North Indian children

  This study looks at children with Kawasaki disease to see if certain scoring systems can help identify those who don't respond to standard treatment, focusing on kids from Europe and North India.

  Recruiting at 17 sites Meyer Children's Hospital IRCCS · Rio de Janeiro and 26 other locations · NCT06305611

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.