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Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04509219
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
In this study, the investigator plan to prescribe Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery lesions or aneurysm formation beyond acute stage to investigate the role for vasculitis of KD or regression of dilatation.

Condition or disease Intervention/treatment Phase
Mucocutaneous Lymph Node Syndrome Drug: Methylprednisolone Injection Phase 1

Detailed Description:

Kawasaki disease is the most common systemic vasculitis in children. Coronary artery aneurysms may develop in 20-25% of untreated patients. Intravenous immune globulin (IVIG) can reduce coronary-artery aneurysms to 3-5%. Numerous studies and clinical trials had pointed out that corticosteroid treatment (pulse therapy or not) could lower the incidence of coronary artery abnormality in high-risk KD patients. However, the therapeutic effect of corticosteroid in KD patients with aneurysm formation after acute stage was never mentioned. There is no effective treatment for aneurysm formation available in KD after acute stage. Methylprednisolone pulse therapy (MP pulse) was used for treatment of KD during acute stage since more than 20 years ago. MP pulse plus IVIG seems not benefit for KD patients but benefit for IVIG resistant KD patients or for high-risk group of CAL formation/ IVIG resistance group. MP pulse therapy is well document used in autoimmune disease vasculitis such as SLE, rheumatoid arthritis, dermatomyosis...etc. Taking together, MP pulse is effective and safe for KD patients during acute stage. In this study, the investigators plan to use MP pulse in KD patients with CAL or aneurysm formation beyond acute stage to investigate the role of vasculitis of KD or regression of dilatation.

Methods: The investigators conducted a prospective study of methylprednisolone pulse therapy (MP pulse) for KD patients with coronary aneurysm or dilatation formation. The investigators will enroll these patients to receive methylprednisolone pulse (MP pulse, 30mg/kg, Max:1g/day for continue 3 days) for treatment. Together with other anti-inflammatory oral medicine including monteleukast, Dextromethorphan(DXM), prednisolone, and ketotifen as supplementary treatment.

The specific aim of this study is the regression of coronary artery aneurysm after MP pulse therapy.

Under the hypothesis and specific aim, the investigators plan to do in the following 3 years:

  1. During the 1st year, the investigators will enroll for 5-10 cases for safety surveys including blood pressure monitoring, inflammatory markers, liver function, renal function, electrolyte imbalance, growth problems as Phase I study.
  2. In the 2nd and 3rd year of this study, the investigators will enroll for 20-30 cases for an effective survey as Phase II study.

Results from this study will help clinicians to treat aneurysm formation or coronary artery dilatation in KD patients and reduce the activity limitation of patients, reduce the medical resource in those patients. The investigators may provide the first treatment for aneurysm in KD.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single arm, phase 1 study of methylprednisolone pulse therapy safety in treatment of aneurysm or coronary artery dilation of Kawasaki disease.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : August 31, 2023


Arm Intervention/treatment
Experimental: Participants treated with MP pulse
Selected participants will be given MP pulse treatment
Drug: Methylprednisolone Injection
methylprednisolone pulse therapy, 30mg/kg, with maximal dose of 1000mg/day, for continue 3 days.
Other Name: methylprednisolone pulse therapy




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 4 weeks from enrollment ]
    Measurement of body weight in Kilogram

  2. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 8 weeks from enrollment ]
    Measurement of body weight in Kilogram

  3. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 12 weeks from enrollment ]
    Measurement of body weight in Kilogram

  4. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 16 weeks from enrollment ]
    Measurement of body weight in Kilogram

  5. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 20 weeks from enrollment ]
    Measurement of body weight in Kilogram

  6. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 24 weeks from enrollment ]
    Measurement of body weight in Kilogram

  7. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 4 weeks from enrollment ]
    Measurement of body height in centimeter

  8. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 8 weeks from enrollment ]
    Measurement of body height in centimeter

  9. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 12 weeks from enrollment ]
    Measurement of body height in centimeter

  10. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 16 weeks from enrollment ]
    Measurement of body height in centimeter

  11. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 20 weeks from enrollment ]
    Measurement of body height in centimeter

  12. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 24 weeks from enrollment ]
    Measurement of body height in centimeter

  13. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 4 weeks from enrollment ]
    Measurement of blood pressure & intraocular pressure in mmHg

  14. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 8 weeks from enrollment ]
    Measurement of blood pressure & intraocular pressure in mmHg

  15. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 12 weeks from enrollment ]
    Measurement of blood pressure & intraocular pressure in mmHg

  16. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 16 weeks from enrollment ]
    Measurement of blood pressure & intraocular pressure in mmHg

  17. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 20 weeks from enrollment ]
    Measurement of blood pressure & intraocular pressure in mmHg

  18. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 24 weeks from enrollment ]
    Measurement of blood pressure & intraocular pressure in mmHg

  19. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 4 weeks from enrollment ]
    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

  20. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 8 weeks from enrollment ]
    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

  21. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 12 weeks from enrollment ]
    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

  22. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 16 weeks from enrollment ]
    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

  23. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 20 weeks from enrollment ]
    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

  24. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 24 weeks from enrollment ]
    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

  25. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 4 weeks from enrollment ]
    Measurement of Calcium & Fibrinogen level in blood in mg/dl

  26. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 8 weeks from enrollment ]
    Measurement of Calcium & Fibrinogen level in blood in mg/dl

  27. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 12 weeks from enrollment ]
    Measurement of Calcium & Fibrinogen level in blood in mg/dl

  28. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 16 weeks from enrollment ]
    Measurement of Calcium & Fibrinogen level in blood in mg/dl

  29. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 20 weeks from enrollment ]
    Measurement of Calcium & Fibrinogen level in blood in mg/dl

  30. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 24 weeks from enrollment ]
    Measurement of Calcium & Fibrinogen level in blood in mg/dl

  31. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 4 weeks from enrollment ]
    Measurement of prothrombin time & activated partial thromboplastin time in second

  32. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 8 weeks from enrollment ]
    Measurement of prothrombin time & activated partial thromboplastin time in second

  33. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 12 weeks from enrollment ]
    Measurement of prothrombin time & activated partial thromboplastin time in second

  34. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 16 weeks from enrollment ]
    Measurement of prothrombin time & activated partial thromboplastin time in second

  35. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 20 weeks from enrollment ]
    Measurement of prothrombin time & activated partial thromboplastin time in second

  36. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 24 weeks from enrollment ]
    Measurement of prothrombin time & activated partial thromboplastin time in second

  37. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 4 weeks from enrollment ]
    Measurement of protein C & protein S level in %

  38. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 8 weeks from enrollment ]
    Measurement of protein C & protein S level in %

  39. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 12 weeks from enrollment ]
    Measurement of protein C & protein S level in %

  40. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 16 weeks from enrollment ]
    Measurement of protein C & protein S level in %

  41. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 20 weeks from enrollment ]
    Measurement of protein C & protein S level in %

  42. Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms [ Time Frame: 24 weeks from enrollment ]
    Measurement of protein C & protein S level in %


Secondary Outcome Measures :
  1. Echocardiography on the coronary artery lesion of Kawasaki disease [ Time Frame: 4 weeks from enrollment ]
    Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.

  2. Echocardiography on the coronary artery lesion of Kawasaki disease [ Time Frame: 8 weeks from enrollment ]
    Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.

  3. Echocardiography on the coronary artery lesion of Kawasaki disease [ Time Frame: 12 weeks from enrollment ]
    Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.

  4. Echocardiography on the coronary artery lesion of Kawasaki disease [ Time Frame: 16 weeks from enrollment ]
    Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.

  5. Echocardiography on the coronary artery lesion of Kawasaki disease [ Time Frame: 20 weeks from enrollment ]
    Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.

  6. Echocardiography on the coronary artery lesion of Kawasaki disease [ Time Frame: 24 weeks from enrollment ]
    Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kawasaki disease patients with coronary artery dilation or aneurysm formation after acute stage (at lease 3 weeks after IVIG treatment)

Exclusion Criteria:

  • patients meet the contraindications of Methylprednisolone sodium succinate, e.g., allergic to Methylprednisolone sodium succinate, premature infant, immune system related thrombocytopathy, immunodeficiency, any congenital diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509219


Contacts
Layout table for location contacts
Contact: Ho-Chang Kuo, MD; PhD +886-7-7317123 ext 8320 erickuo48@yahoo.com.tw

Locations
Layout table for location information
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung City, Taiwan, 83301
Contact: Ho-Chang Kuo, MD, PhD    +886-7-7317123 ext 8320    erickuo48@yahoo.com.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04509219    
Other Study ID Numbers: MP pulse in KD
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Chang Gung Memorial Hospital:
Kawasaki Disease
aneurysm formation
coronary artery dilatation
Methylprednisolone
Pulse therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Mucocutaneous Lymph Node Syndrome
Coronary Aneurysm
Dilatation, Pathologic
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Vasculitis
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists