RecruitingRare disease

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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)
Step 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
Step 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
Step 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
Step 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
Step 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 trial?

13 criteria

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 trial?

13 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Assistance Publique Hopitaux De Paris
Paris, France
Verified
Centre Hospitalier De Versailles
Le Chesnay-Rocquencourt, France

Trial locations

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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.

What is already known about the treatment

Anakinra
A prescription medication administered through subcutaneous injection that works as an interleukin-1 receptor antagonist, primarily used to treat various inflammatory conditions including Kawasaki disease. This biological drug functions by blocking the activity of interleukin-1, a key protein involved in inflammation, thereby reducing fever and other inflammatory symptoms. Currently established in medical literature as a potential second-line treatment option for patients who don't respond to standard IVIG therapy, Anakinra belongs to the class of biological disease-modifying antirheumatic drugs (DMARDs).
Intravenous Immunoglobulin (IVIG)
A blood product administered through intravenous infusion that contains pooled antibodies collected from thousands of blood donors. This medication serves as the standard first-line treatment for Kawasaki disease, working by modulating the immune system and reducing inflammation throughout the body. IVIG belongs to the class of immune globulin therapies and is well-documented in medical literature for its effectiveness in treating various autoimmune and inflammatory conditions, with its primary mechanism involving the regulation of immune system responses and reduction of inflammation.

Investigated diseases

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.