UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000556 |
|---|---|
| Receipt number | 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 12:37:46 |
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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
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
masatomo@kcu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kidney Care Unit in Kyushu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000674
