UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002424 |
|---|---|
| Receipt number | R000002969 |
| Scientific Title | Assessment of pleiotropic and proteinuria reducing effect of irbesartan and losartan in chronic kidney disease patients |
| Date of disclosure of the study information | 2009/09/07 |
| Last modified on | 2020/03/16 12:39:01 |
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Basic information
Public title
Assessment of pleiotropic and proteinuria reducing effect of irbesartan and losartan in chronic kidney disease patients
Acronym
Pleiotropic effect of irbesartan and losartan in chronic kidney disease patients
Scientific Title
Assessment of pleiotropic and proteinuria reducing effect of irbesartan and losartan in chronic kidney disease patients
Scientific Title:Acronym
Pleiotropic effect of irbesartan and losartan in chronic kidney disease patients
Region
| Japan |
Condition
Condition
Chronic kidney disease stage 1-4
Classification by specialty
| Nephrology |
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 and losartan 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
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
irbesartan
Interventions/Control_2
losartan
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
03-3784-8000
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, Shinagawaku, Tokyo, Japan
TEL
03-3784-8000
Homepage URL
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
Showa University Ethics commitee
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | 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
| 2020 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002969
