UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006222 |
|---|---|
| Receipt number | R000007365 |
| Scientific Title | Clarification of pathophysiological roles of prorenin and (pro)renin receptor in hypertension, endocrine disorders and metabolic disorders |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2015/03/15 17:50:37 |
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Basic information
Public title
Clarification of pathophysiological roles of prorenin and (pro)renin receptor in hypertension, endocrine disorders and metabolic disorders
Acronym
Clarification of pathophysiological roles of prorenin and (pro)renin receptor in diseases
Scientific Title
Clarification of pathophysiological roles of prorenin and (pro)renin receptor in hypertension, endocrine disorders and metabolic disorders
Scientific Title:Acronym
Clarification of pathophysiological roles of prorenin and (pro)renin receptor in diseases
Region
| Japan |
Condition
Condition
hypertension
endocrine disorders
metabolic disorders
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify pathophysiological roles of prorenin and soluble (pro)renin receptor [(P)RR] in patients with hypertension, endocrine disorders and metabolic disorders, by measuring their plasma/urine levels, and evaluate their utilities as early marker for organ damages and as parameter to stratify patients according to risk of developing organ damages.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma/urine levels of prorenin and soluble (pro)renin receptor
Key secondary outcomes
1. Blood tests: biochemical measurements, hormones, oxidative stress markers, inflammatory markers, renin
2. Urine tests: pH, albumin/creatinine, hormones, oxidative stress markers, renin
3. Imaging tests: X-rays, CT, MRI, echography
4. Physiological tests: ECG, flow-mediated dilataion(FMD), cardio-anke vascular index(CAVI), augmentaion index(AI), ankle-brachial index(ABI), 24 hours ambulatory blood pressure monitoring(ABPM), visceral/subcutaneous fat ratio measurement
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient who fulfills more than one of the diagnostic criteria of hypertension, endocrine disorders and metabolic dis orders
2. Patient who has been signed the consent form after sufficiently informed and fully understood the study
Key exclusion criteria
1. Patient with chronic kidney disease (CKD) stage 4 or 5
2. Patient whom director of the study disqualified
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Ichihara |
Organization
Tokyo Women's Medical University
Division name
Department of medicine II
Zip code
Address
8-1, Kawada-cho, Shinjuku-ward, Tokyo, Japan
TEL
03-3353-8111
atzichi@endm.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanako Bokuda |
Organization
Tokyo Women's Medical University
Division name
Department of medicine II
Zip code
Address
8-1, Kawada-cho, Shinjuku-ward, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
kanakobkd@endm.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study, which examines associations between plasma/urine levels of prorenin /soluble (pro)renin receptor and organ damages through randomized samples
Management information
Registered date
| 2011 | Year | 08 | Month | 24 | Day |
Last modified on
| 2015 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007365
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
