UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046194 |
|---|---|
| Receipt number | R000052620 |
| Scientific Title | Factors Determining Long-Term Prognosis among Patients on Hemodialysis |
| Date of disclosure of the study information | 2021/11/26 |
| Last modified on | 2021/11/26 13:23:02 |
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Basic information
Public title
Factors Determining Long-Term Prognosis among Patients on Hemodialysis
Acronym
Factors Determining Long-Term Prognosis among Patients on Hemodialysis
Scientific Title
Factors Determining Long-Term Prognosis among Patients on Hemodialysis
Scientific Title:Acronym
Factors Determining Long-Term Prognosis among Patients on Hemodialysis
Region
| Japan |
Condition
Condition
Patients undergoing hemodialysis
Classification by specialty
| Cardiology | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether low physical function and low physical activity increases the risk of cardiovascular events or death.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All cause-mortality and cardiovascular hospitalizations
Key secondary outcomes
Physical function, Physical activity, Cognitive function, Depressive symptoms, ADL performance, and QOL
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
Outpatients with chronic kidney disease undergoing maintenance hemodialysis therapy at 3 times a week
Key exclusion criteria
1)Cognitive dysfunction
2)Significant myocardial ischemia during low-intensity exercise
3)Presence of a recent hospitalization (< 3 month)
4)Ongoing severe arrhythmia
5)Patients with inadequate oxygenation
6)Patients with uncontrolled diabetes
7)Recent cardiovascular events
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiko |
| Middle name | |
| Last name | Matsunaga |
Organization
Kitasato University Graduate School
Division name
Medical Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL
042-778-9970
atsuhikonet@gmail.com
Public contact
Name of contact person
| 1st name | Atsuhiko |
| Middle name | |
| Last name | Matsunaga |
Organization
Kitasato University Graduate School
Division name
Medical Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL
042-778-9970
Homepage URL
atsuhikonet@gmail.com
Sponsor or person
Institute
Graduate School of Medical Sciences, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Sciences, Kitasato University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Dialysis facilities cooperated with Kitasato University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Allied Health Sciences, Kitasato University
Address
1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
Tel
042-778-8896
inouek@kitasato-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
北里大学と連携した透析クリニック (神奈川県、東京都、兵庫県など)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 26 | 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
| 2002 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2002 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2002 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After the baseline survey, prospective observation will be conducted, and physical function are evaluated at regular intervals (approximately one year).
Management information
Registered date
| 2021 | Year | 11 | Month | 26 | Day |
Last modified on
| 2021 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052620
| Research Plan | |
|---|---|
| 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 |
