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 UMIN000000708
Receipt No. R000000844
Scientific Title Efficacy and Safety of mizoribine for MPO-ANCA associated vasculitis; A multicenter randomized controlled trial (Mizoribin for ANCA RPGN Relapse-Prevention study:MARPGN study)
Date of disclosure of the study information 2007/05/06
Last modified on 2013/05/07

* 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 Efficacy and Safety of mizoribine for MPO-ANCA associated vasculitis; A multicenter randomized controlled trial (Mizoribin for ANCA RPGN Relapse-Prevention study:MARPGN study)
Acronym MARPGN study
Scientific Title Efficacy and Safety of mizoribine for MPO-ANCA associated vasculitis; A multicenter randomized controlled trial (Mizoribin for ANCA RPGN Relapse-Prevention study:MARPGN study)
Scientific Title:Acronym MARPGN study
Region
Japan

Condition
Condition MPO-ANCA associated vasculitis
Classification by specialty
Medicine in general Nephrology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess efficacy and safety of mizoribine monitoring the serum concentration for MPO-ANCA associated vasculitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes BVAS score, time from remmision to relapse, relapse rate
Key secondary outcomes MPO-ANCA titer, CRP, GFR, amount dose of corticosteroid through the study

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 treatment with mizoribine according to the GFR once a day
Interventions/Control_2 no treatment with mizoribine
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients in remmision state of
ANCA-associated vasculitis
Key exclusion criteria Patients with allergy with Mizoribine
Patients with leucocytosis(<3000/mm3)
Patients treated with other immunosuppression drug within four weeks
Target sample size 126

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro Yamagata
Organization Division of Clinical Sciences, Faculty of Medicine, University of Tsukuba
Division name Department of Nephrology
Zip code
Address 1-1-1,Ten-nodai,Tsukuba,Ibaraki
TEL 029-853-3202
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiro Yamagata
Organization Division of Clinical Sciences, Faculty of Medicine, University of Tsukuba
Division name Department of Nephrology
Zip code
Address 1-1-1,Ten-nodai,Tsukuba,Ibaraki
TEL 029-853-3202
Homepage URL
Email kidney@md.tsukuba.ac.jp

Sponsor
Institute Department of Nephrology, Division of Clinical Sciences, Faculty of Medicine, University of Tsukuba
Institute
Department

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

Other related organizations
Co-sponsor none
Name of secondary funder(s) Asahi Kasei Pharma Corporation

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 05 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2007 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 05 Month 06 Day
Last modified on
2013 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000844

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.