UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057814 |
|---|---|
| Receipt number | R000066082 |
| Scientific Title | Changes over time in muscle mass, muscle strength, etc. in patients with conservative chronic kidney disease Prospective observation study |
| Date of disclosure of the study information | 2025/05/09 |
| Last modified on | 2025/05/09 15:49:16 |
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Basic information
Public title
Changes over time in muscle mass, muscle strength, etc. in patients with conservative chronic kidney disease Prospective observation study
Acronym
Changes over time in muscle mass, muscle strength, etc. in patients with conservative chronic kidney disease Prospective observation study
Scientific Title
Changes over time in muscle mass, muscle strength, etc. in patients with conservative chronic kidney disease Prospective observation study
Scientific Title:Acronym
Changes over time in muscle mass, muscle strength, etc. in patients with conservative chronic kidney disease Prospective observation study
Region
| Japan |
Condition
Condition
patients with conservative chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to find factors that influence muscle mass and strength in patients with chronic kidney disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SMI
Key secondary outcomes
sppb grip strength lower limb muscle strength
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who participated in a randomized controlled trial on the safety of protein restriction in patients with conservative chronic kidney disease and gave consent.
Key exclusion criteria
Using steroids.
In use of pacemaker or ICD.
Deemed inappropriate by the investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka general medical center
Division name
Department of kidney disease and hypertension
Zip code
5588558
Address
558 Bandai Higashi, Sumiyoshi-ku, Osaka City
TEL
0666921201
bosuhiro2005@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka general medical center
Division name
Department of kidney disease and hypertension
Zip code
5588558
Address
558 Bandai Higashi, Sumiyoshi-ku, Osaka City
TEL
0666921201
Homepage URL
bosuhiro2005@yahoo.co.jp
Sponsor or person
Institute
Osaka general medical center
Institute
Department
Personal name
Funding Source
Organization
osaka general medical center
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
Osaka general medical center
Address
osakacity sumiyoshiku bandaihigasi558
Tel
0666921201
bosuhiro2005@yahoo.co.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 | 05 | Month | 09 | 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
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 09 | 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
none in particular
Management information
Registered date
| 2025 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066082
