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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011510
Receipt No. R000013466
Scientific Title Association of the use of vitamin D receptor activators with incident cardiovascular disease and death after it in hemodialysis patients
Date of disclosure of the study information 2013/10/10
Last modified on 2014/09/01

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Basic information
Public title Association of the use of vitamin D receptor activators with incident cardiovascular disease and death after it in hemodialysis patients
Acronym Association of the use of vitamin D receptor activators with incident cardiovascular disease and death after it in hemodialysis patients
Scientific Title Association of the use of vitamin D receptor activators with incident cardiovascular disease and death after it in hemodialysis patients
Scientific Title:Acronym Association of the use of vitamin D receptor activators with incident cardiovascular disease and death after it in hemodialysis patients
Region
Japan

Condition
Condition Hemodialysis patients
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether the use of vitamin D receptor activators (VDRAs) predicts incident cardiovascular disease (CVD) and death after CVD
Basic objectives2 Others
Basic objectives -Others To examine associations of other CKD-MBD-related factors with incident CVD and death after CVD
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Incident CVD (composite of myocardial infarction, cerebral infarction and cerebral bleeding)
2) Death after CVD
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Prevalent hemodialysis patients at the end of 2004,
1) receiving thrice weekly hemodialysis
2) age between 20 and 90 years old
3) No previous history of myocardial infarction, cerebral infarction or cerebral bleeding
Key exclusion criteria The subjects are excluded if any of the following data is unavailable;
1) the use/nonuse of VDRAs, age, sex, dialysis vintage, underlying kidney disease (diabetic or not), serum calcium, phosphate, intact PTH, albumin, CRP and body mass index at the end of 2004.
2) Information of past history of myocardial infarction, cerebral infarction or cerebral bleeding, and vital state (if dead, the cause of death) at the end of 2005.
Target sample size 49659

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Shoji
Organization Japanese Society for Dialysis Therapy (JSDT)
Division name Committee of Renal Data Registry
Zip code
Address 2-38-21, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL 03-5800-0790
Email t-shoji@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuo Shoji
Organization Osaka City University Graduate School of Medicine
Division name Department of Geriatrics and Vascular Medicine
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3930
Homepage URL
Email t-shoji@med.osaka-cu.ac.jp

Sponsor
Institute Japanese Society for Dialysis Therapy, Committee of Renal Data Registry (JSTD-CRDR)
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 10 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We extracted 49,659 hemodialysis patients at the end of 2004. VDRAs were used in 57% of the subjects at baseline. We identified 3134 patients with incident CVD and 373 deaths after the events. The use of VDRAs was an independent predictors of lower risk of incident CVD, but not a risk factor of death after CVD.

Management information
Registered date
2013 Year 08 Month 18 Day
Last modified on
2014 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013466

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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