Non Inferiority KawasakI Trial With Anakinra

Launched by MEYER CHILDREN'S HOSPITAL IRCCS · Nov 18, 2024

Keywords

ClinConnect Summary

The Non-Inferiority Kawasaki Trial is a study looking at a new treatment for Kawasaki Disease (KD) called anakinra, comparing it to the standard treatment known as intravenous immunoglobulin (IVIG). The goal of the study is to see if anakinra can effectively control fever and prevent serious heart problems, like coronary artery dilation or aneurysms, within a year of starting treatment. This trial will involve multiple medical centers and will recruit patients of all genders, aged between 30 days and 5 years old, who have been diagnosed with Kawasaki Disease based on specific symptoms.

To take part in this study, children must have a fever for at least 5 days along with other symptoms like a rash or swollen lymph nodes, or they may have a shorter fever with more severe symptoms. Participants will be randomly assigned to receive either anakinra or IVIG and will be monitored for their health outcomes. This study is important because it may provide new insights into effective treatments for Kawasaki Disease, which can have serious complications if not treated properly.

Gender

ALL

Eligibility 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