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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017119
Receipt No. R000019756
Scientific Title Menatetrenone Intervention for Dialysis Patients with ArterioSclerosis
Date of disclosure of the study information 2015/04/15
Last modified on 2017/07/11

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Basic information
Public title Menatetrenone Intervention for Dialysis Patients with ArterioSclerosis
Acronym MIDAS study
Scientific Title Menatetrenone Intervention for Dialysis Patients with ArterioSclerosis
Scientific Title:Acronym MIDAS study
Region
Japan

Condition
Condition Patients with chronic kidney disease
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Influence of vitamin K treatment on bone, frailty, and vascular change
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone mineral density, vascular calcification , frailty, and prognosis
Key secondary outcomes Oxidative stress: malondialdehyde, 8OHdG, AOPP, pentosidine, GSH. inflammation: high-sensitivity CRP, IL-6, TNF, pentraxin, troponin T. nutrition: BMI, albumin et al.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 With vitamin K (menatetrenone 45 mg)
Interventions/Control_2 Without 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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients on maintenance hemodialysis without iron deficiency anemia
Key exclusion criteria Receiving warfarin, pregnacy, hypersensitivity, liver dysfunction, thrombosis
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Nakanishi
Organization Hyogo College of Medicine
Division name Dep Internal Medicine, Div Kidney and Dialysis
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6521
Email jin@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukiko Hasuike
Organization Hyogo College of Medicine
Division name Dep Internal Medicine, Div Kidney and Dialysis
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6521
Homepage URL
Email cherry39@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Meiwa hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 兵庫医科大学(兵庫県),明和病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 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
2015 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 15 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 13 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019756

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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