UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047740 |
|---|---|
| Receipt number | R000054426 |
| Scientific Title | Investigation of QALY in patients with chronic renal failure undergoing different renal replacement therapies. |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2023/05/13 11:08:54 |
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Basic information
Public title
Examining Changes in Quality of Life Over Time in Patients with Chronic Kidney Disease
Acronym
Examining Changes in Quality of Life Over Time in Patients with Chronic Kidney Disease
Scientific Title
Investigation of QALY in patients with chronic renal failure undergoing different renal replacement therapies.
Scientific Title:Acronym
Investigation of QALY in patients with chronic renal failure undergoing different renal replacement therapies.
Region
| Japan |
Condition
Condition
Chronic kidney failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aim to investigate differences in QALYs between different renal replacement therapies.
Basic objectives2
Others
Basic objectives -Others
This study examine factors affect QALY.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of Life
QALY
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
Patients who are not receiving any concomitant therapy, whose condition is stable, and whose attending physician and the patient have agreed to participate.
Key exclusion criteria
No hospitalization during the first half year of the measurement, no acute illness currently under treatment, impaired cognitive function required for the measurement, and no consent for participation.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yabe |
Organization
Seirei Christopher University
Division name
Department of Physical therapy, School of Rehabilitation Sciences
Zip code
433-8558
Address
3453 Mikatahara, Kita-ku, Hamamatsu
TEL
0534391400
yabe0909@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yabe |
Organization
Seirei Christopher University
Division name
Department of Physical therapy, School of Rehabilitation Sciences
Zip code
433-8558
Address
3453 Mikatahara, Kita-ku, Hamamatsu
TEL
0534391400
Homepage URL
yabe0909@gmail.com
Sponsor or person
Institute
Seirei Christopher University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Christopher University
Address
3453 Mikatahara, Kita-ku, Hamamatsu
Tel
0534391400
hiroki-y@seirei.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
| 2022 | Year | 09 | Month | 30 | 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
| 2021 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measuring changes in quality of life over time
Management information
Registered date
| 2022 | Year | 05 | Month | 12 | Day |
Last modified on
| 2023 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054426
| 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 |
