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Recruitment status
Unique ID issued by UMIN UMIN000023772
Receipt No. R000027114
Scientific Title Cross-sectional and longitudinal assessment of uremia-related substances' concentration associated with kidney function in chronic kidney disease patients
Date of disclosure of the study information 2016/09/01
Last modified on 2016/08/26

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Basic information
Public title Cross-sectional and longitudinal assessment of uremia-related substances' concentration associated with kidney function in chronic kidney disease patients
Acronym Cross-sectional and longitudinal assessment ofuremia-related substances' concentration associated with kidney function in chronic kidney disease patients
Scientific Title Cross-sectional and longitudinal assessment of uremia-related substances' concentration associated with kidney function in chronic kidney disease patients
Scientific Title:Acronym Cross-sectional and longitudinal assessment ofuremia-related substances' concentration associated with kidney function in chronic kidney disease patients
Region
Japan

Condition
Condition Chronic kidney disease, stage 3-5
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the association between sialidase activity and kidney function in CKD patients by cross-sectional and longitudinal analyses.
Basic objectives2 Others
Basic objectives -Others To investigate whether dialysis itself affects sialidase activity and to explore biomarkers as the predictior of myopathy and dyslipidemia which are likely to be associated with poor prognosis in chronic kidney disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sialidase activity
Key secondary outcomes Erythroferrone, Myostatin, Apelin

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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients with CKD (stage 3-5) doing outpatient visits to the department of Kidney Disease and Hypertension, Osaka General Medical Center
Key exclusion criteria Patients with malignant tumor (including hematologic malignancy), hematologic disease, hepatic cirrhosis, severe infection, severe cognitive impairment, or apparent hemorrhagic lesion. Patients who are judged to be inappropriate for the study participants by principal investigator or subinvestigators.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Terumasa Hayashi
Organization Osaka General Medical Center
Division name Department of Kidney Disease and Hypertension
Zip code
Address 3-1-56 Bandaihigashi, Sumiyoshi-ku, Osaka
TEL +81-6-6692-1201
Email t-hayashi@abelia.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Terumasa Hayashi
Organization Osaka General Medical Center
Division name Department of Kidney Disease and Hypertension
Zip code
Address 3-1-56 Bandaihigashi, Sumiyoshi-ku, Osaka
TEL +81-6-6692-1201
Homepage URL
Email t-hayashi@abelia.ocn.ne.jp

Sponsor
Institute Osaka General Medical Center
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Chugai Pharmaceutical Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 E179
Org. issuing International ID_1 Chugai Pharmaceutical Co., Ltd.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
Date of protocol fixation
2015 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 5 ml of blood sample will be collected at enrollment in addition to a regular blood sampling and 2 ml plasma will be prepared. If patients will start dialysis during 2 years' observation period, additional blood sampling (5 mL) will be done before and after the first dialysis session. If patients will not commence dialysis after 2 years from the enrollment, one additional blood sampling (5 ml) will be done at the end of the observation period.

Management information
Registered date
2016 Year 08 Month 26 Day
Last modified on
2016 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027114

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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