UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039025 |
|---|---|
| Receipt number | R000044432 |
| Scientific Title | Multicenter observational study for chronic dialysis patients |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2021/06/28 12:43:49 |
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Basic information
Public title
Multicenter observational study for chronic dialysis patients
Acronym
Yamato Dialysis Cohort Study
Scientific Title
Multicenter observational study for chronic dialysis patients
Scientific Title:Acronym
Yamato Dialysis Cohort Study
Region
| Japan |
Condition
Condition
End stage kidney disease (hemodialysis)
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the underlying diseases, dialysis conditions, anticoagulation therapy, liver function, electrolyte abnormalities, complications, and prognosis in chronic hemodialysis patients.
Basic objectives2
Others
Basic objectives -Others
Prospective cohort study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
All-cause mortality
Death due to cardiovascular disease, infectious disease, and malignancy
Key secondary outcomes
Congestive heart failure, coronary artery disease, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, obstructive arteriosclerosis, fracture, vascular access-related complications, Performance Status
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 with end-stage kidney disease receiving maintenance dialysis at the participating dialysis clinics
Key exclusion criteria
Patients who are determined to be inappropriate for participation in this study by the investigators
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Tsuruya |
Organization
Nara Medical University
Division name
Department of Nephrology
Zip code
634-8521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-29-8865
tsuruya@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Tanabe |
Organization
Nara Medical University
Division name
Department of Nephrology
Zip code
634-8521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-29-8865
Homepage URL
kaori-ta@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Department of Nephrology
Institute
Department
Personal name
Funding Source
Organization
None
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
Nara Medical University Certified Review Board
Address
840 Shijo-cho Kashihara Nara
Tel
0744-29-8835
ethics_nara@naramed-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 | 12 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective cohort study
Management information
Registered date
| 2019 | Year | 12 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044432
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
