UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000192 |
|---|---|
| Receipt number | 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 16:30:24 |
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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
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
ytatsuo@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000261
