UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006168 |
|---|---|
| Receipt number | R000007290 |
| Scientific Title | Cohort study of Dialysis-Related Endocrine And Metabolic changes affecting cardiovascular disease |
| Date of disclosure of the study information | 2011/08/13 |
| Last modified on | 2014/02/13 10:31:23 |
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Basic information
Public title
Cohort study of Dialysis-Related Endocrine And Metabolic changes affecting cardiovascular disease
Acronym
DREAM Cohort Study
Scientific Title
Cohort study of Dialysis-Related Endocrine And Metabolic changes affecting cardiovascular disease
Scientific Title:Acronym
DREAM Cohort Study
Region
| Japan |
Condition
Condition
Hemodialysis patients
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of endocrine and metabolic changes on clinical outcomes including cardiovascular disease in hemodialysis patients
Basic objectives2
Others
Basic objectives -Others
To generate hypotheses regarding novel treatments by exploring the association of clinical outcomes with serum/plasma markers of endocrine and metabolic changes or with related medications.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause mortality, cardiovascular mortality, non-cardiovascular mortality, incident cardiovascular disease
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients
Key exclusion criteria
1. Patients treated with peritoneal dialysis
2. Hemodialysis patients without informed concent
Target sample size
500
Research contact person
Name of lead principal investigator
| 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
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
t-shoji@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Dialysis Outcome Research Foundation, Tokyo, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
| 2011 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=22764194
Number of participants that the trial has enrolled
Results
Number of patients enrolled: 518
Follow-up period: 5 years
All-cause mortality: 107
Any cardiovascular events: 190
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
| 2004 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 12 | 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
1) DHEA-S was a predictor of all-cause mortality in male hemodialysis patients.
2) EPA/AA ratio was a predictor of incident cardiovascular disease in hemodialysis patients.
3) One of biomarkers of oxidative stress was a predictor of all-cause mortality in hemodialysis patients.
Management information
Registered date
| 2011 | Year | 08 | Month | 13 | Day |
Last modified on
| 2014 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007290
