UMIN-CTR Clinical Trial

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
Email	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
Email	yosukeyama@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045239