Non Inferiority KawasakI Trial With Anakinra
- Conditions
- Kawasaki DiseaseAnakinra
- Interventions
- Drug: Intravenous Immunoglobulins, Human
- Registration Number
- NCT06697431
- Lead Sponsor
- Meyer Children's Hospital IRCCS
- 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.
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 38
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anakinra Anakinra Anakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day Intravenous immunoglobulins Intravenous Immunoglobulins, Human IVIG 2g/kg administered in 10-12 hours as per local standard of care
- Primary Outcome Measures
Name Time Method Number of patients with treatment response in both treatment arms 12 months Response rate
Number of patients with CAA (as per Z-scores) at the end of the study period in both treatment arms 12 months 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
- Secondary Outcome Measures
Name Time Method Number of days with fever in both treatment arms 90 days Fever as defined as T\>38°C
Time to reach CRP values<50% from the highest value and to normalize it in both treatment arms (days) 90 days CRP values expressed in mg/dL
Time to normalize coronary artery abnormalities (days) 90 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
Severity of coronary artery abnormalities (as per Z-score) at the end of follow-up 24 months 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
Length of hospitalization in both treatment arms (days) 90 days Defined by days of hospitalization from disease onset to discharge
Time to stop anakinra (days) 90 days From the first administration iv to the last sc
Adverse event and severe adverse event developed during the study and follow/up period 24 months Medical Dictionary for Regulatory Activities (MeDRA) will be used for the description of adverse events (AEs), according to the regulatory requirements
Cumulative drug exposure (mg/kg/day) 12 months Calculated for both iv e sc administration