UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effect of blood purification therapy on the immune system
Acronym	Study on the effect of blood purification therapy on the immune system
Scientific Title	Study on the effect of blood purification therapy on the immune system
Scientific Title:Acronym	Study on the effect of blood purification therapy on the immune system
Region	Japan

Condition
Condition	All diseases requiring blood purification therapy
Classification by specialty	Nephrology Neurology Clinical immunology Intensive care medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effects on autoimmune diseases, renal failure, septicemia, etc. on the immune system brought about by blood purification therapy and to use it for the treatment and selection of the target disease is there.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number og Myeroid-derived suppressor cells
Key secondary outcomes

Base
Study type	Observational

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases in which various blood purification therapy is performed in our artificial kidney section and intensive care section.
Key exclusion criteria	Cases in which consent was not obtained.
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shigeto Oda
Organization	Chiba University Graduate school of medicine and Chiba University Hospital
Division name	Department of Emergency and Critical Care Medicine an department of Artificial Kidney
Zip code
Address	1-8-1Inohana Chuoku Chiba City and Chiba,Japan
TEL	043-222-7171
Email	nanayayacar@yahoo.co.jp

Public contact
1st name of contact person	1st name Middle name Last name Hanae Wakabayashi
Organization	Chiba University Graduate school of medicine and Chiba University Hospital
Division name	Department of Emergency and Critical Care Medicine an department of Artificial Kidney
Zip code
Address	1-8-1Inohana Chuoku Chiba City and Chiba,Japan
TEL	043-222-7171
Homepage URL
Email	nanayayacar@yahoo.co.jp

Sponsor
Institute	Chiba-University Hospital
Institute
Department

Funding Source
Organization	Scholarship donation
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
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

Other administrative information
Date of disclosure of the study information	2017 Year 05 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	No longer recruiting
Date of protocol fixation	2016 Year 09 Month 01 Day
Date of IRB	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 08 Day
Last follow-up date	2019 Year 03 Month 30 Day
Date of closure to data entry	2019 Year 03 Month 30 Day
Date trial data considered complete	2019 Year 03 Month 30 Day
Date analysis concluded

Other
Other related information	Blood tests before and after treatment, blood tests after remission are performed and data analysis is in progress.

Management information
Registered date	2017 Year 04 Month 26 Day
Last modified on	2019 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031092