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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015066
Receipt No. 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

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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
Email 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
Email m.katsuomi@marianna-u.ac.jp

Sponsor
Institute Department of Nephrology and Hypertension, Internal Medicine, St. Marianna University School of Medi
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017529

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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