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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032000
Receipt No. R000036525
Scientific Title A single center non randomized open-label comparative study using historical controls to verify the effectiveness of plasma exchange therapy for patients with anti-MDA 5 antibody positive rapidly progressive interstitial pneumonia
Date of disclosure of the study information 2018/04/01
Last modified on 2018/06/07

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Basic information
Public title A single center non randomized open-label comparative study using historical controls to verify the effectiveness of plasma exchange therapy for patients with anti-MDA 5 antibody positive rapidly progressive interstitial pneumonia
Acronym Efficacy of plasma exchange therapy for anti-MDA5 antibody positive interstitial pneumonia
Scientific Title A single center non randomized open-label comparative study using historical controls to verify the effectiveness of plasma exchange therapy for patients with anti-MDA 5 antibody positive rapidly progressive interstitial pneumonia
Scientific Title:Acronym Efficacy of plasma exchange therapy for anti-MDA5 antibody positive interstitial pneumonia
Region
Japan

Condition
Condition Interstitial pneumonia
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Validate the usefulness of plasma exchange therapy for refractory anti-MDA5 antibody positive interstitial pneumonia
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
Dynamic allocation
Institution consideration
Blocking
Concealment

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 Patient who was newly developed or relapsed this time diagnosed as anti-MDA5 antibody positive interstitial pneumonia which is treatment-resistant to standard treatment acquired agreement over 20 years in writing.
Key exclusion criteria When there is withdrawal of consent of research cooperation from research subjects.
When the whole research is canceled.
In cases where the researcher judges that the cancellation of research is appropriate for other reasons.
When adverse reactions with difficult plasma continuation therapy appear.
Target sample size 5

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

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Abe
Organization Juntendo university
Division name Department of Internal Medicine and Rheumatology
Zip code
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 Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 順天堂大学医学部附属順天堂醫院

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
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
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
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036525

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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