Comparing Anakinra versus Immunoglobulin for Treatment-Resistant Kawasaki Disease in Patients Who Failed Initial Immunoglobulin Therapy

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What is this study about?

This study focuses on Kawasaki disease, a condition that causes inflammation in blood vessels throughout the body. The research compares two different treatments for patients who did not respond well to their initial therapy. The treatments being studied are Anakinra, which is given as an injection under the skin, and intravenous immunoglobulin (IVIG), which is given through a vein.

The purpose of this research is to determine which of these two treatments works better in reducing fever in patients with Kawasaki disease who did not improve after their first standard treatment. The study will use Kineret (the brand name for Anakinra) as an injection and Privigen (a type of immunoglobulin) as an infusion.

During the study, patients will receive either Anakinra injections or a second round of immunoglobulin treatment. The doctors will monitor the patients’ temperature and overall health status. They will also check the patients’ heart health using special tests, as Kawasaki disease can affect the heart’s blood vessels. The study will continue to monitor patients for several weeks to ensure their safety and to see how well the treatments work.

1 Initial Assessment

Your temperature will be measured to confirm fever of ≥38°C after the first IVIG (intravenous immunoglobulin) treatment

A medical examination will check for signs of Kawasaki disease, including skin changes, rash, eye redness, mouth changes, and enlarged neck lymph nodes

Your doctor will perform necessary tests and an echocardiogram (heart ultrasound)

2 Treatment Assignment

You will be randomly assigned to receive either:

Option 1: A second IVIG treatment given through an intravenous infusion

Option 2: Anakinra treatment given as an injection under the skin

3 Treatment Period

Your temperature will be monitored regularly for the first 48 hours after treatment starts

The medical team will assess your response to treatment

Any injection site reactions or other side effects will be recorded

4 Follow-up at Day 14

Your doctor will evaluate your disease activity

Your parent/guardian will complete an assessment of your condition

The medical team will check for any side effects

5 30-Day Assessment

Blood tests will be performed to check CRP (a marker of inflammation) levels

Your overall health status will be evaluated

Any ongoing side effects will be documented

6 Final Evaluation at Day 45

A final echocardiogram will be performed to check your heart

The medical team will complete a final assessment of your condition

All treatment outcomes will be documented

Who Can Join the Study?

Must be a child aged between 3 months and 18 years
Must weigh at least 5 kilograms
Must have Kawasaki disease with the following symptoms:
- Fever lasting 5 or more days (or at least 3 days if other criteria are present)
- At least 4 of these 5 signs:
  - Changes in hands and feet
  - Skin rash
  - Red eyes without discharge
  - Red and swollen lips or mouth
  - Swollen neck lymph node larger than 1.5 cm (usually on one side)
Must not have responded to standard treatment, shown by:
- Continued or returning fever (38°C or higher) within 24-48 hours after receiving initial treatment
- Fever must have lasted between 5 and 11 days
Must have written consent from patient, parents, or legal guardian
Must have health insurance
Female patients of childbearing age must use effective contraception during the study

Who Cannot Join the Study?

Previous treatment with biological agents (medications that target specific parts of the immune system) in the past 6 months
Known allergic reactions to IVIG (Intravenous Immunoglobulin) or Anakinra
Presence of active bacterial infections
Severe liver dysfunction (poor liver function)
Severe kidney dysfunction (poor kidney function)
Immunodeficiency disorders (conditions that weaken the immune system)
Current participation in other clinical trials
Inability to follow study procedures
Presence of other serious medical conditions that could interfere with the study
Pregnancy or breastfeeding
History of tuberculosis or positive TB test
Active malignancy (cancer)
History of severe allergic reactions to medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Argalxpnyu Pmgqjbnc Hkrlhrls Df Msrbbnmdm	Marseille	France
Czvptj Hutwhlqgbsw Rosbxvnt Uhtaeskyhpqge Dt Tpcej	Tours	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	20.10.2023

Trial locations

Investigated drugs:

Anakinra
An injectable medication that works by blocking a protein called interleukin-1 (IL-1), which is involved in inflammation. It helps reduce fever and inflammation in patients with Kawasaki Disease who didn’t respond well to initial treatment.

Intravenous Immunoglobulin (IVIG)
A treatment made from donated blood plasma containing healthy antibodies. It’s given through an intravenous line (IV) directly into the bloodstream. This therapy helps fight inflammation and supports the immune system in patients with Kawasaki Disease.

Investigated diseases:

Kawasaki's disease

Kawasaki Disease – A rare inflammatory condition that primarily affects children under the age of five. The disease causes inflammation in the walls of blood vessels throughout the body, particularly affecting the coronary arteries. It typically begins with a high fever that lasts for five days or more, accompanied by a rash, red eyes, swollen lymph nodes, and changes in the mouth and throat. Children may also experience redness and swelling of the hands and feet. The inflammation develops in phases, with symptoms appearing and changing over about two weeks.

Trial ID:

2024-516244-25-00

Protocol code:

APHP200009

NCT ID:

NCT04656184

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparing Anakinra versus Immunoglobulin for Treatment-Resistant Kawasaki Disease in Patients Who Failed Initial Immunoglobulin Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?