UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036598
Receipt number 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 2022/10/27 11:14:48

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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

To clarify the significance of biomarkers for cardiovascular disease 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

Association of biomarkers for cardiovascular disease such as Pentraxin 3 and soluble lectin-like oxidized LDL receptor-1 with cardiovascular events in hemodialysis patients for 2 years follow-up period

Key secondary outcomes

Clinical and laboratory factors associated with Pentraxin 3 and soluble lectin-like oxidized LDL receptor-1 levels in hemodialysis patients including all cause mortality


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. Minimal dialysis vintage 3 month
3. Age more than 20 years old and older
4. Patients who can understand the purpose and content of this study and give written informed consent

Key exclusion criteria

1.Patients with active infectious disease
2.History of autoimmune disease
3.History of malignancy
4.Kidney transplantation planned

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 or person

Institute

Department of General Medicine, Hirosaki University Hospital

Institute

Department

Personal name



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

256

Results

A total of 256 participants were finally enrolled on May 20, 2020 through the screening for eligibility since May 2019.

One patient was found to have recent history of operation for renal cell carcinoma and was excluded from analysis.

Results date posted

2020 Year 05 Month 21 Day

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

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.Prospective observational study
2.Patients are enrolled from May 7,2019 to April 30, 2019 according to the inclusion criteria.
3.Participants are prospectively followed for 2 years to investigate associations of biomarkers at baseline with cardiovascular evens.


Management information

Registered date

2019 Year 04 Month 25 Day

Last modified on

2022 Year 10 Month 27 Day



Link to view the page

Value
https://center6.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