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NCT06697431 | NOT YET RECRUITING | Kawasaki Disease

Non Inferiority KawasakI Trial With Anakinra
Sponsor:

Meyer Children's Hospital IRCCS

Information provided by (Responsible Party):

Gabriele Simonini

Brief Summary:

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 development of coronary artery dilation/aneurisms (CAA) within one year from the onset.

Condition or disease

Kawasaki Disease

Anakinra

Intervention/treatment

Anakinra

Intravenous Immunoglobulins, Human

Phase

PHASE4

Detailed Description:

This is a multicenter national, open label, randomized, controlled, interventional trial followed by a long-term observational extension period. This is a non-inferiority study Patients who fulfill the eligibility criteria and whose parent/carer (legal representative) has provided informed consent will be randomized 1:1 to receive either 1. IVIG 2g/kg administered in 10-12 hours as per local standard of care (standard treatment) OR 2. Anakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day (investigational treatment) PLUS Aspirin (ASA) 50mg/kg QID until 36 hours from fever disappearance, then switched to low-dose (3-5 mg/Kg once a day) as per standard of care

Study Type : INTERVENTIONAL
Estimated Enrollment : 38 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Randomized, Controlled, Open-label, Non Inferiority KawasakI Trial With Anakinra
Actual Study Start Date : 2025-04-01
Estimated Primary Completion Date : 2026-04-01
Estimated Study Completion Date : 2027-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Month to 16 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. KD defined in at least one of the three following ways as per American Heart Association (AHA) criteria: Fever for at least 5 days in addition to 4 of the following 5 clinical criteria
    • * bilateral non-purulent conjunctivitis
    • * cervical lymphadenopathy
    • * polymorphous skin rash
    • * changes in lips or mucosa (strawberry tongue, red cracked lips, diffuse erythematous oropharynx)
    • * extremity changes (erythema, oedema of palms and soles in initial phase, and at convalescent stage skin peeling)
    • 2. less than 5 days of fever but all 5 clinical criteria above
    • 3. incomplete KD cases defined as
      • * children/adolescents (\>1 year old) with fever greater than or equal to 5 days AND at least 2 other compatible clinical criteria as listed above;
      • * OR infants ≤ 1 year old with fever greater than or equal to 7 days without other explanation;
      • AND for both age groups, CRP ≥30 mg/L or erythrocyte sedimentation rate (ESR) ≥40 mm/hr (or both) AND for both age groups EITHER the presence of any 3 or more of: anaemia for age (haemoglobin \< lower limit of normal reference range for local laboratory); platelet count ≥450,000/L or \<140,000/L; albumin \<30 g/L; elevated ALT (\> upper limit of normal reference range for local laboratory); white cell count ≥15,000/L; urine ≥10 white blood cells per high power field iv.
      • OR abnormal echocardiogram compatible with KD but without established CAA, with ≥ 3 of the following suggestive features: decreased left ventricular function, mitral regurgitation, pericardial effusion, or dilated but non-aneurysmal coronary arteries (internal diameter 2≤Z\<2.5; and not meeting the exclusion criteria for aneurysmal change as defined below).
      • 4. To be enrolled children need to show persistent fever ≤7 days
      • 5. Written informed consent from an appropriate legal representative(s), and assent from patients older than 7 years
      Exclusion Criteria
    • 1. Patients with KD and already established coronary artery aneurysms (CAA), as per AHA definition, at screening.
    • 2. Clinical picture consistent with Kawasaki Shock Syndrome (KDSS) or Macrophage Activation Syndrome (MAS) OR Multisystem Inflammatory Syndrome in Children (MIS-C)
    • 3. History or evidence of any previous heart disease
    • 4. Known hypersensitivity to anakinra, IVIG and ASA or any medical condition that contraindicates the use of these treatments
    • 5. Patients with KD receiving IVIG, corticosteroids, immunosuppressants, biologic treatments at the time of screening
    • Non Inferiority KawasakI Trial With Anakinra

    Location Details

    NCT06697431

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