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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000192
Receipt No. R000000261
Scientific Title Urinary Angiotensinogen as a Marker of Intrarenal Angiotensin II Activity in Patients with Chronic Renal Disease
Date of disclosure of the study information 2005/09/13
Last modified on 2008/03/31

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Basic information
Public title Urinary Angiotensinogen as a Marker of Intrarenal Angiotensin II Activity in Patients with Chronic Renal Disease
Acronym Urinary Angiotensinogen in Chronic Renal Disease
Scientific Title Urinary Angiotensinogen as a Marker of Intrarenal Angiotensin II Activity in Patients with Chronic Renal Disease
Scientific Title:Acronym Urinary Angiotensinogen in Chronic Renal Disease
Region
Japan

Condition
Condition Chronic renal diseases
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the potential of urinary angiotensinogen as a marker of intrarenal angiotensin II activity in patients with chrinic renal diseases.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between urinary angiotensinogen and deterioration of renal function.
Key secondary outcomes Effects of administration of angiotensin receptor blocker on circulating and urinary angiotensinogen levels.

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with chronic kidney disease
Key exclusion criteria Patients treated with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuo Yamamoto
Organization Hamamatsu University School of Medicine
Division name First Department of Medicine
Zip code
Address 1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
TEL 053-435-2261
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuo Yamamoto
Organization Hamamatsu University School of Medicine
Division name First Department of Medicine
Zip code
Address 1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
TEL 053-435-2261
Homepage URL
Email ytatsuo@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine.
The Ministry of Education, Culture, Sports, Science and Technology, Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Faculty of Applied Biological Science,
Gifu University
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
2005 Year 09 Month 13 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
The results showing that urinary angiotensinogen levels could be used as a marker of intrarenal angiotensin II activity associated with increased risk for deterioration of renal function in patients with chronic kidney disease has been published in J. Am. Soc. Nephrol. 18:1558-1565, 2007.
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
2003 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2003 Year 02 Month 01 Day
Last follow-up date
2006 Year 03 Month 01 Day
Date of closure to data entry
2006 Year 05 Month 01 Day
Date trial data considered complete
2006 Year 07 Month 01 Day
Date analysis concluded
2006 Year 12 Month 01 Day

Other
Other related information Prospective observational study, random sampling in CKD patients.

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2008 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000261

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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