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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000556
Receipt No. R000000674
Scientific Title A prospective cohort study of mineral and bone disorder in hemodialysis patients
Date of disclosure of the study information 2007/03/07
Last modified on 2014/09/12

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Basic information
Public title A prospective cohort study of mineral and bone disorder in hemodialysis patients
Acronym Q-Cohort Study
Scientific Title A prospective cohort study of mineral and bone disorder in hemodialysis patients
Scientific Title:Acronym Q-Cohort Study
Region
Japan

Condition
Condition chronic renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the risk factors of all-cause mortality, cardiovascular events, and bone fracture
Basic objectives2 Others
Basic objectives -Others a prospective cohort study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes All-cause mortality
Key secondary outcomes The influence of dialysate calcium concentration on the mortality , cardiovascular disease, bone fracture in hemodialysis patients
The influence of dialysis time on either the mortality or the condition in hemodialysis patients
The influence of vitamin D therapy on either the mortality or the condition in hemodialysis patients
The risk factor of mortaliry, cardiaovascular disease and bone fracture in hemodialysis patients
The relationship between PTH/PTH fragment and the condition of hemodialysis patiens
The change of the condition by newly drugs in hemodialysis patients

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hemodialysis patients
Key exclusion criteria The patients who do not agree with this study
The patients who are unsuitable for this study
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Tsuruya
Organization Kyushu University
Division name Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL 0926425843
Email tsuruya@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masatomo Taniguchi
Organization Kyushu University Hospital
Division name Kidney Care Unit
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka city
TEL 0926425843
Homepage URL
Email masatomo@kcu.med.kyushu-u.ac.jp

Sponsor
Institute Kidney Care Unit in Kyushu University Hospital
Institute
Department

Funding Source
Organization The Society of the Treatment for Kidney Disease
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
Address
Tel
Email

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
2007 Year 03 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The risks of both cardiovascular desease and bone fracture in vitamin D treated group were significantly higher than those in non-treated group.
The risks of both cardiovascular desease and bone fracture inreased in the hyperparathyroidism patients, but not in the hypoparathyroidism patients.
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 No longer recruiting
Date of protocol fixation
2006 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 12 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective cohort study, mutiple centers collaboration

Management information
Registered date
2006 Year 12 Month 24 Day
Last modified on
2014 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000674

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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