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Non Inferiority KawasakI Trial With Anakinra

ConditionsKawasaki DiseaseAnakinra
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-16
SponsorMeyer Children's Hospital IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

bilateral non-purulent conjunctivitis

cervical lymphadenopathy

polymorphous skin rash

changes in lips or mucosa (strawberry tongue, red cracked lips, diffuse erythematous oropharynx)

Disqualifiers

To be enrolled children need to show persistent fever ≤7 days

Written informed consent from an appropriate legal representative(s), and assent from patients older than 7 years

Patients with KD and already established coronary artery aneurysms (CAA), as per AHA definition, at screening.

Clinical picture consistent with Kawasaki Shock Syndrome (KDSS) or Macrophage Activation Syndrome (MAS) OR Multisystem Inflammatory Syndrome in Children (MIS-C)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anakinra

    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, Human

    Drug

    see previous section

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: AnakinraExperimental treatment 1 intervention
Group B: Intravenous immunoglobulinsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with treatment response in both treatment arms

Response rate

Time frame
12 months
2

Number of patients with CAA (as per Z-scores) at the end of the study period in both treatment arms

CAA rate in both arms. CAAs will be classified in accordance with the scheme based on Z scores proposed by AHA. No coronary involvement with Z score \<2, dilation only with Z score \> 2 to \<2.5 or if initially \<2 with a decrease during follow-up ≥1 3, small aneurysm with Z score ≥2.5 to \<5, medium aneurysm with Z score ≥5 to \<10 and absolute dimension \<8 mm and large or giant aneurysm with Z score ≥10, or absolute dimension ≥8 mm

Time frame
12 months

Secondary outcomes

1

Number of days with fever in both treatment arms

Fever as defined as T\>38°C

Time frame
90 days
2

Time to reach CRP values<50% from the highest value and to normalize it in both treatment arms (days)

CRP values expressed in mg/dL

Time frame
90 days
3

Time to normalize coronary artery abnormalities (days)

CAAs will be classified in accordance with the scheme based on Z scores proposed by AHA. No coronary involvement with Z score \<2, dilation only with Z score \> 2 to \<2.5 or if initially \<2 with a decrease during follow-up ≥1 3, small aneurysm with Z score ≥2.5 to \<5, medium aneurysm with Z score ≥5 to \<10 and absolute dimension \<8 mm and large or giant aneurysm with Z score ≥10, or absolute dimension ≥8 mm

Time frame
90 days
4

Severity of coronary artery abnormalities (as per Z-score) at the end of follow-up

CAAs will be classified in accordance with the scheme based on Z scores proposed by AHA. No coronary involvement with Z score \<2, dilation only with Z score \> 2 to \<2.5 or if initially \<2 with a decrease during follow-up ≥1 3, small aneurysm with Z score ≥2.5 to \<5, medium aneurysm with Z score ≥5 to \<10 and absolute dimension \<8 mm and large or giant aneurysm with Z score ≥10, or absolute dimension ≥8 mm

Time frame
24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Meyer Children's Hospital IRCCS

Lead sponsor

Asst Degli Spedali Civili Di Brescia

Collaborator

IRCCS Burlo Garofolo

Collaborator

Source ClinicalTrials.gov

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