UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020384 |
|---|---|
| Receipt number | R000023363 |
| Scientific Title | Development of novel treatment strategy to prevent progression of arteriosclerosis in dialysis patients |
| Date of disclosure of the study information | 2015/12/28 |
| Last modified on | 2016/01/06 16:57:20 |
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Basic information
Public title
Development of novel treatment strategy to prevent progression of arteriosclerosis in dialysis patients
Acronym
Development of novel treatment strategy to prevent progression of arteriosclerosis in dialysis patients
Scientific Title
Development of novel treatment strategy to prevent progression of arteriosclerosis in dialysis patients
Scientific Title:Acronym
Development of novel treatment strategy to prevent progression of arteriosclerosis in dialysis patients
Region
| Japan |
Condition
Condition
end stage renal disease
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are (1) to define the biological or physiological markers reflecting early arteriosclerosis, (2) to clarify the clinical risk factors for progression of arteriosclerosis, and (3) to plan the therapeutic protocol for suppressing progression of atherosclerosis in dialysis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Vascular physiological function tests, imaging studies, peritoneal equilibration tests, and blood and urinary tests
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients of 15 years and over with end-stage renal disease on peritoneal dialysis or hemodialysis at Kansai Medical University Hirakata hospital or Kansai Medical University Takii hospital.
Key exclusion criteria
not available
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsutaka Nakahigashi |
Organization
Kansai Medical University Hirakata hospital
Division name
second department of internal medicine
Zip code
Address
Shinmachi 2-5-1, Hirakata, Osaka, Japan
TEL
072-804-0101
nakahimi@tnoc.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsutaka Nakahigashi |
Organization
Kansai Medical University Hirakata hospital
Division name
second department of internal medicine
Zip code
Address
Shinmachi 2-5-1, Hirakata, Osaka, Japan
TEL
072-804-0101
Homepage URL
nakahimi@tnoc.kmu.ac.jp
Sponsor or person
Institute
second department of internal medicine, Kansai Medical University Hirakata hospital
Institute
Department
Personal name
Funding Source
Organization
second department of internal medicine, Kansai Medical University Hirakata hospital
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
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
| 2015 | Year | 12 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2006 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | 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 register the patients with end-stage renal disease on peritoneal dialysis or hemodialysis followed-up in Kansai Medical University Hirakata hospital or Kansai Medical University Takii hospital to investigate risk factors for progression of arteriosclerosis.
Research design: Cross-sectional Study
Methods to recruit subjects: all matching selection criteria in our hospital between 01 Jan 2006 and 01 Dec 2018
Item to measure: serum chemistry, baPWV, FMD, head MRI, endothelial progenitor cells, cytokines, vWF, ICAM, AGE, sRAGE, adipocytokines, FGF23, klotho
Management information
Registered date
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2016 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023363
