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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name