UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000470
Receipt number R000000555
Scientific Title Cardiovascular event and atherosclerosis - peritoneal dialysis patients compared with hemodialysis patients.
Date of disclosure of the study information 2006/10/01
Last modified on 2010/01/07 11:38:21

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Basic information

Public title

Cardiovascular event and atherosclerosis - peritoneal dialysis patients compared
with hemodialysis patients.

Acronym

Cardiovascular event and atherosclerosis by dialysis modality.

Scientific Title

Cardiovascular event and atherosclerosis - peritoneal dialysis patients compared
with hemodialysis patients.

Scientific Title:Acronym

Cardiovascular event and atherosclerosis by dialysis modality.

Region

Japan


Condition

Condition

chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will clarify the difference of dialysis modality in cardiovascular
outcome and atherogenicity in newly end stage renal disease patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

frequency of cardiovascular event and factors of atherosclerosis

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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Should be included all;registration by the patients themselves, treated as the first renal replacement therapy

Key exclusion criteria

Should be excluded even if one of them would be positive; Patients under 18, older than 80. Patients with pregnancy or the suspected. Patients treated with both peritoneal dialysis and hemodialysis(combined therapy). Patients transplanted before. Patients decided inapropriate participants by doctors.

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Yorioka

Organization

Graduate School of Biomedical Sciences, Hiroshima University

Division name

Department of Advanced Nephrology

Zip code


Address

1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima prefecture, Japan

TEL

082-257-1506

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yukio Yokoyama

Organization

Graduate School of Biomedical Sciences, Hiroshima University

Division name

Department of Advanced Nephrology

Zip code


Address

1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima prefecture, Japan

TEL

082-257-1506

Homepage URL


Email

masaki@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Department of Advanced Nephrology, Graduate School of Biomedical Sciences, Hiroshima University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

2006 Year 10 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

2006 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2006 Year 10 Month 01 Day

Last follow-up date

2010 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

background,height,bodyweight,BP,clinical symptom,medication,labo test data(blood electrolyte,total protein,albumin,total cholesterol,BUN,creatinine),hANP,CTR,UF,CRP


Management information

Registered date

2006 Year 08 Month 15 Day

Last modified on

2010 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000555


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name