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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011490
Receipt No. 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 2020/08/19

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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 Yukio
Middle name
Last name Yuzawa
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
Email yukio-y@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
Email mhase@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine, Department of Nephrology
Institute
Department

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
Tokaichita Clinic
Hirabarikinen Clinic
Jyuzen Clinic
Tokai Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fujita Health University Ethics Committee
Address Dengakugakubo Kutsukakecho Toyoakeshi
Tel 0562-93-2865
Email 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
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 Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 13 Day
Date of IRB
2019 Year 04 Month 22 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

Other
Other related information

Management information
Registered date
2013 Year 08 Month 14 Day
Last modified on
2020 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013399

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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