UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012870 |
|---|---|
| Receipt number | R000015005 |
| Scientific Title | Clinical evaluation for proximal kidney tubular dysfunction among chronic hepatitis B virus infection patients taking oral antiviral nucleos(t)ide analogues |
| Date of disclosure of the study information | 2014/01/17 |
| Last modified on | 2015/08/26 17:38:39 |
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Basic information
Public title
Clinical evaluation for proximal kidney tubular dysfunction among chronic hepatitis B virus infection patients taking oral antiviral nucleos(t)ide analogues
Acronym
Clinical evaluation for proximal kidney tubular dysfunction among chronic hepatitis B virus infection patients taking oral antiviral nucleos(t)ide analogues
Scientific Title
Clinical evaluation for proximal kidney tubular dysfunction among chronic hepatitis B virus infection patients taking oral antiviral nucleos(t)ide analogues
Scientific Title:Acronym
Clinical evaluation for proximal kidney tubular dysfunction among chronic hepatitis B virus infection patients taking oral antiviral nucleos(t)ide analogues
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to evaluate the prevalence of proximal kidney tubular dysfunction and its related factors among chronic hepatitis B virus infection patients taking oral antiviral nucleos(t)ide analogues.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the cumulative incidence of proximal kidney tubular dysfunction
Key secondary outcomes
related factors of proximal kidney tubular dysfunction (clinical characterisitics and the single-nucleotide polymorphisms in genes)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with chronic hepatits B treated with nucleos(t)ide analogues for more than 1 year
Key exclusion criteria
coinfection with HIV
dialysis patients
patients found to be inadequate by their doctors
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Furusyo |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
furusyo@gim.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohiro Shimizu |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
Homepage URL
smotohir@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of General Internal Medicine, Kyushu University Hospital
Institute
Department
Personal name
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)
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
| 2014 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2012 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study / retrospective study
Management information
Registered date
| 2014 | Year | 01 | Month | 16 | Day |
Last modified on
| 2015 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015005
