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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000000470
Receipt No. 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

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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
Institute Hiroshima University
Institute
Department

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
URL(English) https://upload.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


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