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
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
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
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
