UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical significance of sustained virological response for hepatitis C virus-infected patients on hemodialysis
Title of the study (Brief title)	The clinical significance of sustained virological response for hepatitis C virus-infected patients on hemodialysis
Region	Japan

Condition
Condition	Hepatitis C virus infection
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The clinical significance of sustained virological response for hepatitis C virus-infected patients on hemodialysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Extrahepatic manifestations of hepatitis c.
Key secondary outcomes	Vascular access patency rate, Death, Cardiovascular event.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Hepatitis C virus infected patients on hemodialysis.
Key exclusion criteria	Patients who do not agree with this study.
Target sample size	100

Research contact person
Name of lead principal investigator	Toshinobu Sato
Organization	Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Division name	Department of nephrology
Address	3-16-1 Tsutsumimachi, Aoba-ku, Sendai, Miyagi 981-8501, Japan.
TEL	022-275-3111
Email	sato-toshinobu@sendai.jcho.go.jp

Public contact
Name of contact person	Yasunori Miyasaka
Organization	Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Division name	Department of nephrology
Address	3-16-1 Tsutsumimachi, Aoba-ku, Sendai, Miyagi 981-8501, Japan.
TEL	022-275-3111
Homepage URL
Email	miyasaka.yasunori@gmail.com

Sponsor
Institute	Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 11 Month 02 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 11 Month 02 Day
Anticipated trial start date	2015 Year 11 Month 02 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 05 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective cohort study

Management information
Registered date	2015 Year 10 Month 22 Day
Last modified on	2017 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022485