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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002784
Receipt No. R000001919
Scientific Title The effect of maxacalcitol on cardiovascular disesase in hemodialysis patients
Date of disclosure of the study information 2009/12/01
Last modified on 2012/11/26

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Basic information
Public title The effect of maxacalcitol on cardiovascular disesase in hemodialysis patients
Acronym MAX study
Scientific Title The effect of maxacalcitol on cardiovascular disesase in hemodialysis patients
Scientific Title:Acronym MAX study
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the maxacalcitol treatment prevent cardiovascular disease in hemodialysis patients, as compared with coventional therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Left ventricular mass index
Key secondary outcomes Intimal plus medial complex thickness
Coronary artery calcification score
Pulse wave velocity
Dual energy X-ray absorptiometry
Bone metabolism marker
Inflamatory marker
Oxidative stress marker
Parathyroid gland volume
Correlation between bone and artery
Correlation between vitamin D level and vascular calcification

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Maxacalcitol therapy
Interventions/Control_2 Conventional therpy (oral vitamin D treatment)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Hemodialysis patients
Within 2 years after the initiation of hemodialysis therapy
Serum intact PTH level more than 180pg/ml
Serum corrected calcium level less than 10.0mg/dl
Key exclusion criteria Post history of intravenous vitamin D therapy
Post history of cicalcet HCl treatment
Post history of peritoneal dialysis or kidney transplantion
Pregnant woman
Post history of severe cardiovascular disease
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Tsuruya
Organization Kyushu University, Graduate School of Medical Sciences
Division name Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
TEL 092-642-5843
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masatomo Taniguchi
Organization Kyushu University, Graduate School of Medical Sciences
Division name Department of Medicine and Clinical Science
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
TEL 092-642-5256
Homepage URL
Email masatomo@kcu.med.kyushu-u.ac.jp

Sponsor
Institute Department of Medicine and Clinical Science, Kyushu University
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 01 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
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 19 Day
Last modified on
2012 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001919

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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