UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017885 |
|---|---|
| Receipt number | R000020383 |
| Scientific Title | Relationship between ambulatory blood pressure monitoring and renal tissue injury |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2016/06/09 14:31:26 |
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Basic information
Public title
Relationship between ambulatory blood pressure monitoring and renal tissue injury
Acronym
ABPM and renal tissue damage
Scientific Title
Relationship between ambulatory blood pressure monitoring and renal tissue injury
Scientific Title:Acronym
ABPM and renal tissue damage
Region
| Japan |
Condition
Condition
glomerulonephritis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hypertension is a common complication in chronic kidney disease patients. However, the influence of patterns of HT on renal tissue damage remains unclear.
Basic objectives2
Others
Basic objectives -Others
We investigate the relationship between ambulatory blood pressure monitoring and renal tissue injury in glomerulonephritis.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Renal tissue damage(glomerulosclerosis, interstitial fibrosis, intminal thickening of intra-lobular arteries, artriolar hyalinosis)
Key secondary outcomes
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
over 16 years old
patients with 24hr ABPM
Key exclusion criteria
patients who reject joining this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishi Shinichi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology
Zip code
Address
Kusunoki-cho 7-5-2, Chuou-ku, Kobe city
TEL
078-382-6500
snishi@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kono Keiji |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology
Zip code
Address
Kusunoki-cho 7-5-2, Chuou-ku, Kobe city
TEL
078-382-6500
Homepage URL
kkono@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe university graduate school of medicine
Organization
Division
Category of Funding Organization
Self funding
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
神戸大学病院、明石医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 12 | 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
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
| 2015 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2015 | Year | 06 | Month | 12 | Day |
Last modified on
| 2016 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020383
