UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011510
Receipt number 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 14:42:53

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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