UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of pleiotropic and proteinuria reducing effect of irbesartan in chronic kidney disease patients
Acronym	Pleiotropic effect of irbesartan in chronic kidney disease patients
Scientific Title	Assessment of pleiotropic and proteinuria reducing effect of irbesartan in chronic kidney disease patients
Scientific Title:Acronym	Pleiotropic effect of irbesartan in chronic kidney disease patients
Region	Japan

Condition
Condition	Chronic kidney disease stage 1-4
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the study is to estimate proteinuria reducing and pleiotropic effect of irbesartan in Japanese CKD patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is proteinuria reducing effect at four, twelve and twenty-four months after administration of the ARB case compared with at baseline.
Key secondary outcomes	The secondary outcome is the impact of irbesartan on adiponectin, leptin, IGF-1, hsCRP, IL-6, IL-10. TNF, at four, twelve and twenty-four months after administration of the ARB case compared with at baseline.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	irbesartan
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	1) Renal dysfunction: CKD stage 1-4 2) Expected survival time is more than 6 months 3) Aged 20 years over 4) Fully informed consent was obtained
Key exclusion criteria	1) Patients who has past history of adverse effect of taking another ARB 2) Pregnancy 3) Patients who has serious liver disease and coronary heart disease or nephrotic syndrome 4) Judged inappropriate for this study by the physicians
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hirokazu Middle name Last name Honda
Organization	Showa University School of Medicine
Division name	Division of Nephrology , Depertment of Medicine
Zip code	142-8666
Address	1-5-8, Hatanodai, Shinagawaku, Tokyo, Japan
TEL	0337848533
Email	hondah@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Hirokazu Middle name Last name Honda
Organization	Showa University School of Medicine
Division name	Division of Nephrology Department of Medicine
Zip code	142-8666
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8533
Homepage URL
Email	hondah@med.showa-u.ac.jp

Sponsor
Institute	Division of Nephrology Department of Medicine, Showa University School of Medicine
Institute
Department

Funding Source
Organization	Division of Nephrology Department of Medicine, Showa University School of Medicine
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	Ethics Committee for Research Involving Human Subjects at Showa University School of Medicine
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
Tel	03-3784-8022
Email	mkyoumu@ofc.showa-u.ac.jp

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	2009 Year 09 Month 07 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	Open public recruiting
Date of protocol fixation	2009 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 09 Month 01 Day
Last modified on	2021 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002967