UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057081 |
|---|---|
| Receipt number | R000065243 |
| Scientific Title | Tokai Dialysis Prospective Cohort Study Phase 2 |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2026/02/23 15:53:05 |
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Basic information
Public title
Tokai Dialysis Prospective Cohort Study Phase 2
Acronym
Tokai Dialysis Cohort Study Phase 2
Scientific Title
Tokai Dialysis Prospective Cohort Study Phase 2
Scientific Title:Acronym
Tokai Dialysis Cohort Study Phase 2
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, comorbidities, routine laboratory data, and practice patterns 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
Key secondary outcomes
Cardiovascular event
Bone fracture
Parathyroidectomy
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
| 18 | 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
2500
Research contact person
Name of lead principal investigator
| 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 Shimokasuya, Isehara, 259-1193, Japan
TEL
0463-93-1121
hkomaba@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nakagawa |
Organization
Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
259-1193
Address
143 Shimokasuya, Isehara, 259-1193, Japan
TEL
0463-93-1121
Homepage URL
ysuke_nkgw@tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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 Shimokasuya, Isehara, 259-1193, Japan
Tel
0463-93-1121
tokai-rec@tokai.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
| 2025 | Year | 03 | 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
2209
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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 18 | 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 comorbidities, routine laboratory data, and practice patterns on hospitalization, mortality, and other patient-level outcomes in maintenance hemodialysis patients. Baseline data have been fully collected, and patients are currently being followed for outcomes.
Management information
Registered date
| 2025 | Year | 02 | Month | 19 | Day |
Last modified on
| 2026 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065243
