UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015066 |
|---|---|
| Receipt number | R000017529 |
| Scientific Title | Prospective observational study of atherosclerosis progression in chronic kidney disease |
| Date of disclosure of the study information | 2014/09/06 |
| Last modified on | 2020/03/11 15:33:48 |
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Basic information
Public title
Prospective observational study of atherosclerosis progression in chronic kidney disease
Acronym
Observational study of atherosclerosis progression
Scientific Title
Prospective observational study of atherosclerosis progression in chronic kidney disease
Scientific Title:Acronym
Observational study of atherosclerosis progression
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the contribution of arteriosclerosis risk factors of various to arteriosclerosis progression in chronic kidney disease
Basic objectives2
Others
Basic objectives -Others
Exploratory observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The main outcome was the first onset of fatal or nonfatal cardiovascular events and progression of renal failure, defined as myocardial infarction; stroke; coronary, carotid, or peripheral artery revascularization; initiation of dialysis.
Key secondary outcomes
Contribution of various inspection results for the primary outcome
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
The inclusion criteria for the patients were as follows; (i) the patient was diagnosed with CKD; (ii) the patient had no history of liver disease, cancer, infectious disease, collagen disease or dialysis; and (iii) the patient who was able to perform ambulatory blood pressure monitoring (ABPM) at the enrollment of investigation.
Key exclusion criteria
Patients with recent occurrences of CVD events within the past year were excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Matsui |
| Middle name | |
| Last name | Katsuomi |
Organization
Department of Nephrology and Hypertension, Internal Medicine, St. Marianna University School of Medicine, Kanagawa
Division name
Department of Nephrology and Hypertension, Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki 216-8511, Japan
TEL
81449778511
m.katsuomi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Matsui |
| Middle name | |
| Last name | Katsuomi |
Organization
Department of Nephrology and Hypertension, Internal Medicine, St. Marianna University School of Medi
Division name
Department of Nephrology and Hypertension, Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki 216-8511, Japan
TEL
81449778511
Homepage URL
m.katsuomi@marianna-u.ac.jp
Sponsor or person
Institute
Department of Nephrology and Hypertension, Internal Medicine, St. Marianna University School of Medi
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology and Hypertension, Internal Medicine, St. Marianna University School of Medi
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
St. Marianna University School of Med
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki 216-8511, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
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
聖マリアンナ医科大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 06 | 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
Completed
Date of protocol fixation
| 2006 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2006 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study was a prospective observational study and carried out between November 2007 and December 2012. Adult patients with CKD in the out-patient clinic at the Department of Nephrology and Hypertension, Internal Medicine, St. Marianna University School of Medicine Hospital (Kawasaki, Japan) were eligible for enrollment.
Management information
Registered date
| 2014 | Year | 09 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017529
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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