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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040259
Receipt No. 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 2020/06/16

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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
Email 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/
Email yamada.shunsuke.944@m.kyushu-u.ac.jp

Sponsor
Institute Department of Nephrology, Hypertension, and Strokology, Kyushu University
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 28 Day
Date of IRB
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
Date analysis concluded

Other
Other related information Before enrollment

Management information
Registered date
2020 Year 04 Month 28 Day
Last modified on
2020 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045926

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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