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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036598
Receipt No. R000041661
Scientific Title Evaluations of pathogenesis of cardiovascular disease and cardiovascular event risk in patients undergoing hemodialysis by biomarkers for cardiovascular disease
Date of disclosure of the study information 2019/05/01
Last modified on 2019/05/10

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Basic information
Public title Evaluations of pathogenesis of cardiovascular disease and cardiovascular event risk in patients undergoing hemodialysis by biomarkers for cardiovascular disease
Acronym Biomarkers for cardiovascular disease in hemodialysis patients
Scientific Title Evaluations of pathogenesis of cardiovascular disease and cardiovascular event risk in patients undergoing hemodialysis by biomarkers for cardiovascular disease
Scientific Title:Acronym Biomarkers for cardiovascular disease in hemodialysis patients
Region
Japan

Condition
Condition End-stage renal disease
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidation of the significance of biomarkers in pathogenesis of cardiovascular disease and cardiovascular event risk in patients undergoing hemodialysis
Basic objectives2 Others
Basic objectives -Others Associations of biomarkers for cardiovascular disease with cardiovascular events and vascular calcification
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Factors associated with levels of biomarkers for cardiovascular disease such as Pentraxin 3 and soluble lectin-like oxidized LDL receptor-1 in hemodialysis patients
Key secondary outcomes Cardiovascular events including vascular access troubles and progression of vascular calcification for 2 years observational period

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. Patients undergoing hemodialysis at Oyokyo Kidney Research Institute Hirosaki Hospital
2. Patients who can understand the purpose and content of this study and give written informed consent
Key exclusion criteria 1.Dialysis vintage less than 3 month
2.Age less than 20 years old
3.Patients with active infectious disease
4.Patients with autoimmune disease
5.Patients with malignancy
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Osawa
Organization Hirosaki University Hospital
Division name Department of General Medicine
Zip code 0368563
Address 53 Hon-cho, Hirosaki, Aomori, Japan
TEL 0172395177
Email osawa@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Osawa
Organization Hirosaki University Hospital
Division name Department of General Medicie
Zip code 0368563
Address 53 Hon-cho, Hirosaki, Aomori, Japan
TEL 0172395177
Homepage URL
Email osawa@hirosaki-u.ac.jp

Sponsor
Institute Department of General Medicine, Hirosaki University Hospital
Institute
Department

Funding Source
Organization Oyokyo Kidney Research Institute
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Oyokyo Kidney Research Institute Hirosaki Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Comitee of Medical Ethics of Hirosaki University Graduate School of Medicine
Address 5 Zaifu-cho, Hirosaki, Aomori, Japan
Tel 0172395194
Email jm5194@hirosaki-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

Other administrative information
Date of disclosure of the study information
2019 Year 05 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
2019 Year 03 Month 13 Day
Date of IRB
2019 Year 04 Month 16 Day
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
2022 Year 06 Month 30 Day
Date trial data considered complete
2022 Year 07 Month 20 Day
Date analysis concluded
2022 Year 08 Month 31 Day

Other
Other related information 1.Observational study consisting of cross-sectional study followed by longitudinal study
2.Patients are enrolled from May 7,2019 to April 30, 2019 according to the inclusion criteria.
3.Associations of biomarkers with vascular calcification, history of cardiovascular disease and vascular access troubles, and characteristics of patients at enrollment are investigated by cross-sectional study.
4.Participants are prospectively observed for 2 years and associations of biomarkers with cardiovascular evens, vascular access troubles and progression of vascular calcification are investigated in longitudinal study.

Management information
Registered date
2019 Year 04 Month 25 Day
Last modified on
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041661

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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