UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011490 |
|---|---|
| Receipt number | R000013399 |
| Scientific Title | Evaluation of vascular calcification in relation to biomarker and vitminK in hemodialysis patients |
| Date of disclosure of the study information | 2013/08/15 |
| Last modified on | 2024/03/27 22:06:21 |
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Basic information
Public title
Evaluation of vascular calcification in relation to biomarker and vitminK in hemodialysis patients
Acronym
Vascular calcification in hemodialysis patients
Scientific Title
Evaluation of vascular calcification in relation to biomarker and vitminK in hemodialysis patients
Scientific Title:Acronym
Vascular calcification in hemodialysis patients
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy of vitamin K as an inhibitor of vascular calcification in hemodialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Inhibition of vascular calcification.
Comparison of the progression of the calcification index between vitamin K administration group and control group.
Key secondary outcomes
1. Comparison of vitamin K related biomarkers among between vitamin K administration group and control group.
2.Comparison of the change in DEXA between vitamin K administration group and control group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention
Administration of vitamin K
Administration of 45 mg of menatetrenone orally
Interventions/Control_2
Control
no administration of vitamin K
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age over 18 years old
2. Able to gain the informed consent
Key exclusion criteria
1. Remaining days are less than one year.
2. Women who are pregnant
3. Intake of vitamin K antagonists
4. Known hypersensitivity against vitamin k
5. History of thrombosis
6. Significant liver dysfunction
7. Inflammatory bowel disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Hasegawa |
Organization
Fujita Health University School of Medicine
Division name
Department of Nephrology
Zip code
470-1192
Address
1-98 Dengakugakubo Kutsukakecho Toyoakeshi Aichi
TEL
0562-93-9245
mhase@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Hasegawa |
Organization
Fujita Health University School of Medicine
Division name
Department of Nephrology
Zip code
470-1192
Address
Toyoakeshi Kutsukakecho Dengakugakubo 1-98
TEL
0562-93-9245
Homepage URL
mhase@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine, Department of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School of Medicine, Department of Nephrology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoyakinenzaidan
Kanayama Clinic
Shinseikai Daiichi hospital
Narumi Clinic
Hirabarikinen Clinic
Jyuzen Clinic
Tokai Clinic
Mizuno clinic Mizuhiro Bunin
Okehazama Clinic
Stytaikai Hospital
Oyamada Onsen Hospital
Murase Hospital
Takasu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University Ethics Committee
Address
Dengakugakubo Kutsukakecho Toyoakeshi
Tel
0562-93-2865
f-rib@fujita-hu.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
藤田医科大学 腎臓内科学 Fujita Health University School of Medicine, Department of Nephrology
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | 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
207
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013399
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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