Unique ID issued by UMIN | UMIN000000867 |
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Receipt number | R000001044 |
Scientific Title | Prospective study of the severity-based treatment protocol for Japanese patients with MPO-ANCA-associated vasculitis |
Date of disclosure of the study information | 2007/10/30 |
Last modified on | 2011/11/30 16:57:22 |
Prospective study of the severity-based treatment protocol for Japanese patients with MPO-ANCA-associated vasculitis
JMAAV
Prospective study of the severity-based treatment protocol for Japanese patients with MPO-ANCA-associated vasculitis
JMAAV
Japan |
MPO-ANCA-associated vasculitis
Pneumology | Nephrology | Clinical immunology |
Dermatology |
Others
NO
To study the efficacy and safety of the consensus protocol based on the severity for the treatment of Japanese patients with MPO-ANCA-associated vasculitis. To analyse transcriptomics for the prediction of patients' prognosis.
Safety,Efficacy
Confirmatory
Not applicable
remission induction, permanent renal failure and death
BVAS, VDI, SF-36, adverse effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
IVCY0.5-0.75g/m2 or oral CY 0.5-2.0mg/kg/day
plus prednisolone 0.6-1.0mg/kg/day for the severe cases.
Add plasma exchange for the most severe cases.
Omit cyclophosphamide for aged cases with RPGN and dialysed cases.
Prednisolone 0.5mg/kg alone or in conbination with azathioprine for the mild cases.
Not applicable |
80 | years-old | >= |
Male and Female
MPO-ANCA positive and one of the following criteria determined by the Research Committees of Japanese ministry of Health, Labor and Welfare.
1. criteria for microscopic polyangiitis
2. criteria for polyarteritis nodosa
3. rapidly progressive glomerulonephritis
1. age over 80
2. active infection
3. WBC<4000
4. Platelt < 120,000
5. chronic dialysis
6. severe respiratory failure
7. liver cirrhosis
8. malignancy within 5 years
9. pregnancy
10. previous cumulative cyclophosphamide dosage > 10g
50
1st name | |
Middle name | |
Last name | Shoichi Ozaki |
St. Marianna University School of Medicine
Division of Rheumatology and Allergy, Department of Internal Medicine
2-16-1 Sugao, Miyamae-ku, Kawasaki
044-977-8111
1st name | |
Middle name | |
Last name |
Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of
office
office.mhlw.vasculitis-res@marianna-u.ac.jp
Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of Japan
the Ministry of Health, Labor and Welfare of Japan
Research Committe of Progressive Glomerular Disease of the Ministry of Health, Labor and Welfare of Japan
NO
2007 | Year | 10 | Month | 30 | Day |
http://www.springerlink.com/content/6127p83n20333768/fulltext.pdf
Published
http://www.springerlink.com/content/6127p83n20333768/fulltext.pdf
We (JMAAV [Japanese patients with MPO-ANCA-associated vasculitis] Study Group) performed a prospective, open-label, multi-center trial to evaluate the usefulness of severity-based treatment in Japanese patients with myeloperoxidase-anti-neutrophil cytoplasmic antibodies (MPO-ANCA)-associated vasculitis. Patients with MPO-ANCA-associated vasculitis received a severity-based regimen according to the appropriate protocol: low-dose corticosteroid and, if necessary, cyclophosphamide or azathioprine in patients with mild form; high-dose corticosteroid and cyclophosphamide in those with severe form; and the severe-form regimen plus plasmapheresis in those with the most severe form. We followed up the patients for 18 months. The primary end points were the induction of remission, death, and end-stage renal disease (ESRD). Fifty-two patients were registered, and 48 patients were enrolled in this study (mild form, n = 23; severe form, n = 23; most severe form, n = 2). Among the 47 patients who received the predefined therapies, 42 achieved remission within 6 months, 5 died, and 1 developed ESRD. Disease flared up in 8 of the 42 patients with remission during the 18-month follow-up period. The JMAAV trial is the first prospective trial for MPO-ANCA-associated vasculitis to be performed in Japan. The remission and death rates were comparable to those in several previous clinical trials performed in western counties. The regimen employed in this trial was tailor-made based on patients' disease severity and disease type, and it seems that standardization can be consistent with treatment choices made according to severity.
Completed
2004 | Year | 06 | Month | 07 | Day |
2004 | Year | 09 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2007 | Year | 10 | Month | 29 | Day |
2011 | Year | 11 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001044
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