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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | ||
Condition | Chronic renal diseases | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Prospective observational study, random sampling in CKD patients. |
Management information | |||||||
Registered date |
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Last modified on |
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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 |