UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040259 |
|---|---|
| Receipt number | R000045926 |
| Scientific Title | A cross-sectional study on the skeletal muscle mass estimation in patients with chronic kindey disease |
| Date of disclosure of the study information | 2020/05/20 |
| Last modified on | 2021/04/28 09:52:41 |
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Basic information
Public title
A cross-sectional study on the skeletal muscle mass estimation in patients with chronic kindey disease
Acronym
A cross-sectional study on the skeletal muscle mass estimation in patients with chronic kindey disease
Scientific Title
A cross-sectional study on the skeletal muscle mass estimation in patients with chronic kindey disease
Scientific Title:Acronym
A cross-sectional study on the skeletal muscle mass estimation in patients with chronic kindey disease
Region
| Japan |
Condition
Condition
Chronic kindey disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a new equation that can precisely estimate the amount of skeletal muscle mass
Basic objectives2
Others
Basic objectives -Others
Validation of the serum creatinine/serum cystatin C as a surrogate of skeletal muscle mass
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Skeletal muscle mass measured by bioelectrical impedance analysis
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who were inpatients or outpatients at Kyushu University and meet the following criteria
1) Subjects who had serum levels of creatinine and cystatin C with the same blood sample
2) Subjects who underwent body composition analysis by InBody
3) Subjects can give written informed consent
4) Subjects aged between 20 and 80 years old
Key exclusion criteria
Those who are not suitable for the test judged by the attending physicians
Example 1) Subjects with advanced peripheral edema
Example 2) Subujects with a history of limb amputation
Example 3) Subjects with liver cirrhosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takanari |
| Middle name | |
| Last name | Kitazono |
Organization
Kyushu University Hospital
Division name
Department of Nephrology, Hypertension, and Strokology
Zip code
812-8582
Address
Maidasih 3-1-1, Higashi-Ku, Fukuoka
TEL
092-642-5256
kitazono@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Yamada |
Organization
Kyushu University Hospital
Division name
Department of Nephrology, Hypertension, and Strokology
Zip code
812-8582
Address
Maidasih 3-1-1, Higashi-Ku, Fukuoka
TEL
092-642-5843
Homepage URL
http://www.kcu.med.kyushu-u.ac.jp/
yamada.shunsuke.944@m.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Nephrology, Hypertension, and Strokology, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology, Hypertension, and Strokology, Kyushu University
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
Kyushu University Hospital
Address
Maidasih 3-1-1, Higashi-Ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 20 | 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
182
Results
A total of 181 patients were divided into 100 derivation cohort and 81 validation cohort. An equation to estimate skeletal muscle mass measured by MIA method was created and applied to the validation cohort. The determination of coefficient was 0.729 (P value less than 0.001). Our results suggest that the new equation could be used to CKD patients for the estimation of skeletal muscle mass.
Results date posted
| 2021 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No adverse events were observed.
Outcome measures
Estimated skeletal muscle mass
Plan to share IPD
No plans
IPD sharing Plan description
Not applicable
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
The study enrollment was completed. We will analyze the dataset and publish main results in a journal.
Management information
Registered date
| 2020 | Year | 04 | Month | 28 | Day |
Last modified on
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045926
