UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006609 |
|---|---|
| Receipt number | R000003954 |
| Scientific Title | Effect of irbesartan on progression of chronic kidney disease |
| Date of disclosure of the study information | 2011/10/25 |
| Last modified on | 2012/04/25 12:31:01 |
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Basic information
Public title
Effect of irbesartan on progression of chronic kidney disease
Acronym
Effect of irbesartan on progression of chronic kidney disease
Scientific Title
Effect of irbesartan on progression of chronic kidney disease
Scientific Title:Acronym
Effect of irbesartan on progression of chronic kidney disease
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detremine renoprotective effects of irbesartan are varied with patients of metaboloic syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
1. Change of blood pressure
2. Change of urinary albumin and protein excretion
Key secondary outcomes
Change of serum parameters related to metabolic syndrome (insulin, adiponectin, leptin, hsCRP, TNF alfa, IL-6)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Blood and urine sampling at 4,8 and 24 weeks after admistration of irbesartan.
Volume of blood sampling is 6ml.
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) Chronic kidney disease who were treated at Department of nephrology, Tsukuba University Hosputal, Ibaraki, Japan.
2)Patients who are prescribed irbesartan
3) Patients who gave written infromed consent
Key exclusion criteria
1) Patients with hypertensive crisis
2) Pregant or possible pregnant patients
3)Bilateral renal artery stenosis
4)anemia (Hb<8g/dl)
5)liver dysfunction (ALT>200IU/L)
6)modelate renal dysfunction(eGFR<40ml/min)
7)hyperkalemia (serum potassium conc. >6mEq/L)
8)Allergic reaction to irbesartan
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiro Yamagata |
Organization
University of Tsukuba
Division name
Nephrology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3202
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Tsuruoka |
Organization
University of Tsukuba
Division name
Nephrology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3202
Homepage URL
Sponsor or person
Institute
Department of Nephrology, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology, University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 25 | 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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 25 | Day |
Last modified on
| 2012 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003954
