UMIN-CTR Clinical Trial

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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