Non Inferiority KawasakI Trial With Anakinra

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-04-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Kawasaki Disease Anakinra

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients who fulfill the eligibility criteria and whose parent/carer (legal representative) have provided informed consent will be randomized 1:1 to receive standard of care IVIG and aspirin or anakinra and ASA.

As epidemiological data suggest worse outcomes in terms of CAA for very young patients (age \<1 years), in this setting, proper randomisation 1:1 procedure will be matched for age \< or\> than 1 year

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anakinra

Anakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day

Group Type EXPERIMENTAL

Anakinra

Intervention Type DRUG

Patients who fulfill the eligibility criteria a 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)

Patients showing fever, between 36 hours and 72 hours from the end of first line treatment will be considered failures. Failures from the investigational treatment arm will receive a dose of IVIG and they will drop from the study.

Children who remained afebrile between the 36th and 72nd hour will be considered as responders, and they will proceed into the study.

Patients in the standard treatment arm will continue ancillary treatment and follow-up .

Patients in the investigational treatment arm will enter the tapering phase.

Intravenous immunoglobulins

IVIG 2g/kg administered in 10-12 hours as per local standard of care

Group Type ACTIVE_COMPARATOR

Intravenous Immunoglobulins, Human

Intervention Type DRUG

see previous section

Interventions

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Anakinra

Patients who fulfill the eligibility criteria a 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)

Patients showing fever, between 36 hours and 72 hours from the end of first line treatment will be considered failures. Failures from the investigational treatment arm will receive a dose of IVIG and they will drop from the study.

Children who remained afebrile between the 36th and 72nd hour will be considered as responders, and they will proceed into the study.

Patients in the standard treatment arm will continue ancillary treatment and follow-up .

Patients in the investigational treatment arm will enter the tapering phase.

Intervention Type DRUG

Intravenous Immunoglobulins, Human

see previous section

Intervention Type DRUG

Other Intervention Names

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Kineret IVIG

Eligibility Criteria

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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.

Exclusion Criteria

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

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No