UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031999
Receipt No. R000036523
Scientific Title A multicenter, cooperative prospective, nonrandomized, open-label, comparative study using historical controls to verify the effectiveness of simple plasma exchange therapy for patients with the most severe form ANCA associated vasculitis
Date of disclosure of the study information 2018/04/01
Last modified on 2020/03/31

* 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 A multicenter, cooperative prospective, nonrandomized, open-label, comparative study using historical controls to verify the effectiveness of simple plasma exchange therapy for patients with the most severe form ANCA associated vasculitis
Acronym Efficacy verification trial of plasma exchange therapy for the most severe form ANCA associated vasculitis
Scientific Title A multicenter, cooperative prospective, nonrandomized, open-label, comparative study using historical controls to verify the effectiveness of simple plasma exchange therapy for patients with the most severe form ANCA associated vasculitis
Scientific Title:Acronym Efficacy verification trial of plasma exchange therapy for the most severe form ANCA associated vasculitis
Region
Japan

Condition
Condition ANCA associated vasculitis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify the effectiveness of plasma exchange therapy for the most severe type ANCA-associated vasculitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes One year survival rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Plasma exchange
Plasma exchange therapy should be performed once with 2.0 to 3.0 L and three times as one course. Nafamostat mesilate is used as an anticoagulant and fresh frozen plasma is used as a replenisher. Until the introduction of remission, the number of enforcement courses will be decided appropriately between 1 and 6 courses depending on the condition. For this reason, the total number of plasma exchange therapies ranges from 3 to a maximum of 18, resulting in a fresh frozen plasma transfusion volume of 6.0 L to 54.0 L.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Fulfill classification criteria for ANCA-associated vasculitis of any age 20 years or older, written in written form, either microscopic polyangiitis, polyangiitis granulomatosis, eosinophilic polyangiitis granulomatosis Patients who have newly developed or relapsed the condition that becomes the most severe type this time.
Key exclusion criteria If there is a withdrawal of consent of research cooperation from the research subject.
When the whole research is canceled.
If for other reasons the researcher judges that the cancellation of research is appropriate.
When adverse reactions with difficult plasma continuation therapy appear.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Naoto
Middle name
Last name Tamura
Organization Juntendo university
Division name Department of Internal Medicine and Rheumatology
Zip code 1130033
Address 2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL 0338133111
Email tnaoto@juntendo.ac.jp

Public contact
Name of contact person
1st name Yoshiyuki
Middle name
Last name Abe
Organization Juntendo university
Division name Department of Internal Medicine and Rheumatology
Zip code 1130033
Address 2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL 0338133111
Homepage URL
Email yo-abe@juntendo.ac.jp

Sponsor
Institute Juntendo university
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University
Address 2-1-1, Hongo, Bunkyo-Ku, Tokyo
Tel 0338133111
Email kenkyu5858@juntendo.ac.jp

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 順天堂大学医学部附属順天堂醫院
順天堂東京江東高齢者医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 30 Day
Date of IRB
2018 Year 03 Month 23 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 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
2018 Year 03 Month 30 Day
Last modified on
2020 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036523

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.