UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000867
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective study of the severity-based treatment protocol for Japanese patients with MPO-ANCA-associated vasculitis
Acronym JMAAV
Scientific Title Prospective study of the severity-based treatment protocol for Japanese patients with MPO-ANCA-associated vasculitis
Scientific Title:Acronym JMAAV
Region
Japan

Condition
Condition MPO-ANCA-associated vasculitis
Classification by specialty
Pneumology Nephrology Clinical immunology
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes remission induction, permanent renal failure and death
Key secondary outcomes BVAS, VDI, SF-36, adverse effects

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichi Ozaki
Organization St. Marianna University School of Medicine
Division name Division of Rheumatology and Allergy, Department of Internal Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of
Division name office
Zip code
Address
TEL
Homepage URL
Email office.mhlw.vasculitis-res@marianna-u.ac.jp

Sponsor
Institute Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of Japan
Institute
Department

Funding Source
Organization the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Research Committe of Progressive Glomerular Disease of the Ministry of Health, Labor and Welfare of Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 10 Month 30 Day

Related information
URL releasing protocol http://www.springerlink.com/content/6127p83n20333768/fulltext.pdf
Publication of results Published

Result
URL related to results and publications http://www.springerlink.com/content/6127p83n20333768/fulltext.pdf
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2004 Year 09 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 10 Month 29 Day
Last modified on
2011 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001044

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.