UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002423
Receipt number R000002967
Scientific Title Assessment of pleiotropic and proteinuria reducing effect of irbesartan in chronic kidney disease patients
Date of disclosure of the study information 2009/09/07
Last modified on 2021/10/05 12:44:11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002967


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name