UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039684 |
|---|---|
| Receipt number | R000045239 |
| Scientific Title | Plasma exchange for Anti-neutrophil cytoplasmic antibodies-associated vasculitis: a systematic review and mata-analysis |
| Date of disclosure of the study information | 2020/03/06 |
| Last modified on | 2020/09/03 10:50:57 |
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Basic information
Public title
Plasma exchange for Anti-neutrophil cytoplasmic antibodies-associated vasculitis: a systematic review and mata-analysis
Acronym
Plasma exchange for ANCA-associated vasculitis: a systematic review
Scientific Title
Plasma exchange for Anti-neutrophil cytoplasmic antibodies-associated vasculitis: a systematic review and mata-analysis
Scientific Title:Acronym
Plasma exchange for ANCA-associated vasculitis: a systematic review
Region
| Japan |
Condition
Condition
Anti-neutrophil cytoplasmic antibodies(ANCA)-associated vasculitis
Classification by specialty
| Medicine in general | Nephrology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess effects of plasma exchange for ANCA-associated vasculitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Mortality, 2 clinical remission, 3 adverse events
Key secondary outcomes
1 Renal failure, 2 Disease flare/relapse, 3 Health-related quality of life, 4 Disease damage
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suffering from ANCA-associated vasculitis including granulomatous with polyangiitis (formerly Wegener's granulomatosis), eosinophilic granulomatous with polyangiitis (formerly Churg-Strauss syndrome), microscopic polyangiitis, or renal-limited vasculitis.
Key exclusion criteria
Patients with other types of vasculitis
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Yamada |
Organization
Shinshu University Hospital
Division name
Department of Nephrology
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto, Nagano
TEL
+81-263-37-2634
yosukeyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Yamada |
Organization
Shinshu University Hospital
Division name
Department of Nephrology
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto, Nagano
TEL
+81-263-37-2634
Homepage URL
yosukeyama@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
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
Shinshu University Hospital
Address
3-1-1 Asahi Matsumoto, Nagano
Tel
+81-263-37-2634
yosukeyama@shinshu-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | 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
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 17 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 20 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 20 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 20 | Day |
Other
Other related information
We will perform a systematic review and meta-analysis.
We will collect randomised controlled trials comparing Plasma exchange (PE) versus non-PE in ANCA-associated vasculitis patients.
Management information
Registered date
| 2020 | Year | 03 | Month | 04 | Day |
Last modified on
| 2020 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045239
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
