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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033365
Receipt No. R000038035
Scientific Title Kyusyu Prospective Cohort Study in Hemodialysis Patients
Date of disclosure of the study information 2018/09/01
Last modified on 2019/07/12

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Basic information
Public title Kyusyu Prospective Cohort Study in Hemodialysis Patients
Acronym Q-Cohort Study
Scientific Title Kyusyu Prospective Cohort Study in Hemodialysis Patients
Scientific Title:Acronym Q-Cohort Study
Region
Japan

Condition
Condition Chronic hemodialysis patients
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate complications and prognosis of patients on Chronic Hemodialysis
Basic objectives2 Others
Basic objectives -Others To investigate the best hemodialysis prescription to patients on chronic hemodialysis
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Death (cardiovascular cause, infectious disease, malignancy)
Key secondary outcomes Coronary heart disease, stroke, peripheral artery disease, bone fracture

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 Patients undergoing chronic hemodialysis
Key exclusion criteria Physician decides the patient inappropriate to participate
Target sample size 3600

Research contact person
Name of lead principal investigator
1st name Takanari
Middle name
Last name Kitazono
Organization Kyushu University
Division name Department of Medicine and Clinical Science
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5843
Email kitazono@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Toshiaki
Middle name
Last name Nakano
Organization Kyushu University
Division name Department of Medicine and Clinical Science
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5843
Homepage URL
Email toshink@med.kyushu-u.ac.jp

Sponsor
Institute ARO Next Generation Medical Center
Institute
Department

Funding Source
Organization Fukuoka Renal Clinic
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for clinical and translational research
Address 3-1-1 Maidashi, Higashi-ku
Tel 0926425774
Email bynintei@jimu.kyushu-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
2018 Year 09 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
2018 Year 10 Month 24 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2018 Year 07 Month 11 Day
Last modified on
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038035

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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