UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Menatetrenone Intervention for Dialysis Patients with ArterioSclerosis
Title of the study (Brief title)	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	Takeshi Nakanishi
Organization	Hyogo College of Medicine
Division name	Dep Internal Medicine, Div Kidney and Dialysis
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6521
Email	jin@hyo-med.ac.jp

Public contact
Name of contact person	Yukiko Hasuike
Organization	Hyogo College of Medicine
Division name	Dep Internal Medicine, Div Kidney and Dialysis
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 04 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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