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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008685
Receipt No. R000006643
Scientific Title Tokai Dialysis Prospective Cohort Study
Date of disclosure of the study information 2012/09/01
Last modified on 2021/02/18

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Basic information
Public title Tokai Dialysis Prospective Cohort Study
Acronym Tokai Dialysis Cohort Study
Scientific Title Tokai Dialysis Prospective Cohort Study
Scientific Title:Acronym Tokai Dialysis Cohort Study
Region
Japan

Condition
Condition End Stage Renal Disease
Classification by specialty
Endocrinology and Metabolism Nephrology Endocrine surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify patient characteristic, practice patterns, routine laboratory data, and other serum markers (e.g. FGF23 and soluble Klotho) that affect hospitalization, mortality, and other patient-level outcomes in maintenance hemodialysis patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All-cause mortality
Cardiovascular mortality
Cardiovascular event
Bone fracture
Parathyroidectomy
Key secondary outcomes

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 Receiving hemodialysis three times weekly for at least three months
Key exclusion criteria None
Target sample size 800

Research contact person
Name of lead principal investigator
1st name Masafumi
Middle name
Last name Fukagawa
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code 259-1193
Address 143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL 0463-93-1121
Email fukagawa@tokai-u.jp

Public contact
Name of contact person
1st name Hirotaka
Middle name
Last name Komaba
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code 259-1193
Address 143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL 0463-93-1121
Homepage URL
Email hkomaba@tokai-u.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization The Kidney Foundation, Japan
The Japanese Association of Dialysis Physicians, Japan
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 Institutional Review Board for Clinical Research, Tokai University
Address 143 Shimo-Kasuya, Isehara, 259-1193, Japan
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.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
2012 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 654
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 No longer recruiting
Date of protocol fixation
2012 Year 08 Month 01 Day
Date of IRB
2012 Year 07 Month 19 Day
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This prospective cohort study examines the impact of patient characteristic, practice patterns, routine laboratory data, and other serum markers (e.g. FGF23 and soluble Klotho) on hospitalization, mortality, and other patient-level outcomes in maintenance hemodialysis patients.

Management information
Registered date
2012 Year 08 Month 14 Day
Last modified on
2021 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006643

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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