UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017881 |
|---|---|
| Receipt number | R000018730 |
| Scientific Title | Association between vascular calcification and exostosin-like glycosaminotransferase 2 (EXTL2) in hemodialysis patients |
| Date of disclosure of the study information | 2015/06/15 |
| Last modified on | 2020/06/25 17:36:22 |
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Basic information
Public title
Association between vascular calcification and exostosin-like glycosaminotransferase 2 (EXTL2) in hemodialysis patients
Acronym
Association between vascular calcification and EXTL2
Scientific Title
Association between vascular calcification and exostosin-like glycosaminotransferase 2 (EXTL2) in hemodialysis patients
Scientific Title:Acronym
Association between vascular calcification and EXTL2
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether EXTL2 is associated with vascular calcification in hemodialysis patients
Basic objectives2
Others
Basic objectives -Others
Association between EXTL2 and vascular calcification
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between EXTL2 and abdominal calcification index (ACI)
Key secondary outcomes
1, Association between EXTL2 and chondroitin sulfate or heparan sulfate
2, Association between serum EXTL2 levels and EXTL2 mRNA in blood
3, Association between EXTL2 and other parameters
4, Difference of serum EXTL2 levels between healthy control and hemodialysis patients
5, Association between vascular calcification and chondroitin sulfate or heparan sulfate
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hemodialysis patients
Key exclusion criteria
1, Inpatients
2, Patients who started hemodialysis within 6 months
3, Diabetic patients
4, Patients whose diameter of abdominal aorta is over three centimeters
5, Patients with surgical history of abdominal aorta
6, Patients who do not agree with participation in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Goto |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology and Kidney Center
Zip code
Address
7-5-2, Kusuhoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6500
sgoto@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Goto |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology and Kidney Center
Zip code
Address
7-5-2, Kusuhoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6500
Homepage URL
sgoto@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Association of Dialysis Physicians
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
Address
Tel
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
社会医療法人愛仁会千船病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 15 | 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
27
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
We require time to complete the paper.
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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2015 | Year | 06 | Month | 11 | Day |
Last modified on
| 2020 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018730
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
