UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032000 |
|---|---|
| Receipt number | 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 | 2023/04/04 09:58:09 |
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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 | 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
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
yo-abe@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university
Institute
Department
Personal name
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
Juntendo University
Address
2-1-1, Hongo, Bunkyo-Ku
Tel
0338133111
yo-abe@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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000036525
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000036525
Number of participants that the trial has enrolled
0
Results
No entry.
Results date posted
| 2023 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
None
Participant flow
None
Adverse events
None
Outcome measures
None
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
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
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036525
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
