UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026677 |
|---|---|
| Receipt number | R000030636 |
| Scientific Title | Epidemiology survey of patients with hepatitis C during hemodialysis |
| Date of disclosure of the study information | 2017/03/24 |
| Last modified on | 2019/10/12 18:27:03 |
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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
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
atsukawa-nms@umin.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokuso Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030636
