UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033365 |
|---|---|
| Receipt number | R000038035 |
| Scientific Title | Kyusyu Prospective Cohort Study in Hemodialysis Patients |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2020/01/10 09:32:48 |
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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
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
toshink@med.kyushu-u.ac.jp
Sponsor or person
Institute
ARO Next Generation Medical Center
Institute
Department
Personal name
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
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
| 2028 | 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
| 2020 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038035
