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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020384
Receipt No. 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

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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
Email 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
Email nakahimi@tnoc.kmu.ac.jp

Sponsor
Institute second department of internal medicine, Kansai Medical University Hirakata hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023363

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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