UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023772 |
|---|---|
| Receipt number | 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 07:39:52 |
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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
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
t-hayashi@abelia.ocn.ne.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027114
