UMIN-CTR Clinical Trial

Basic information
Public title	Epidemiology survey of patients with hepatitis C during hemodialysis
Acronym	Epidemiology survey of patients with hepatitis C during hemodialysis
Scientific Title	Epidemiology survey of patients with hepatitis C during hemodialysis
Scientific Title:Acronym	Epidemiology survey of patients with hepatitis C during hemodialysis
Region	Japan

Condition
Condition	chronic hepatitis C,chronic kidney disease
Classification by specialty	Hepato-biliary-pancreatic medicine Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To search epidemiology investigation of chronic hepatitis C with hemodialysis patients and clarify convalescence and problems. To measure fiborsis and inflamaatory maker of chronic hepatitis C during hemodialysis.
Basic objectives2	Others
Basic objectives -Others	Epidemiology investigation
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positive rate of HCV antibody in patients during hemodialysis Positive rate of HCV RNA in patients during hemodialysis Treatment rate of chronic hepatitis c patients during hemodialysis
Key secondary outcomes	Degree of fibrosis and inflamattory markers of chronic hepatitis C patients during hemodialysis

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	HCV RNA positive patients during hemodialysis enforcement
Key exclusion criteria	none
Target sample size	2500

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokuso Hospital
Division name	Division of Gastroenterology
Zip code
Address	1715 Kamagari Inzai Chiba
TEL	0476991111
Email	atsukawa-nms@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masanori Atsukawa
Organization	NIppon Medical School Chiba Hokuso Hospital
Division name	Division of Gastroenterology
Zip code
Address	0476991111
TEL	0476991111
Homepage URL
Email	atsukawa-nms@umin.ac.jp

Sponsor
Institute	Nippon Medical School Chiba Hokuso Hospital
Institute
Department

Funding Source
Organization	Nippon Medical School Chiba HOkuso Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Mihama Sakura Clinic Mihama Narita Clinic Mihama Katori Clinic Narita Hospital Japanese Red Cross Narita Hospital Mito Saiseikai General Hospital Shinmatsudo Cental General Hospital The Kidney Disease Clinic of Nippon Medical School Gyo-toku General Hospital Ibaraki Prefectural Central Hospital Hakusaido Clinic Abiko Toho Hospital Hakujikai Kinen Genral Hospital Otakanomori Hospital Abiko Seijinkai Hospital Seirei Sakura Citizen Hospital Chibahokusounaika Clinic Siroi Seijinkai Hospital Kobari General Hospital Kobayashi Hospital
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 03 Month 24 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	2016 Year 08 Month 01 Day
Date of IRB	2017 Year 08 Month 03 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Choice and problem of the treatment of patients with chronic hepatitis C during hemodialysis Questionary survey in multiple hemodialysis centers

Management information
Registered date	2017 Year 03 Month 24 Day
Last modified on	2019 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030636