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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002429
Receipt No. R000002972
Scientific Title An observation study concerning peritoneal dysfunction and vascular growth factors in CAPD patients
Date of disclosure of the study information 2009/09/01
Last modified on 2017/03/08

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Basic information
Public title An observation study concerning peritoneal dysfunction and vascular growth factors in CAPD patients
Acronym Peritoneal dysfunction and vascular growth factors
Scientific Title An observation study concerning peritoneal dysfunction and vascular growth factors in CAPD patients
Scientific Title:Acronym Peritoneal dysfunction and vascular growth factors
Region
Japan

Condition
Condition Peritoneal dialysis patients
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate vascular growth factors affecting peritoneal pathological change and dysfunction in CAPD patients
Basic objectives2 Others
Basic objectives -Others The relationship between vascular growth factors and cardiovascular disease in CAPD patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Pathological changes and the expression of VEGF mRNA in peritoneum.
2. Measurements of VEGF protein and soluble VEGF receptor in urine for 24 hours
3. Measurements of VEGF protein and soluble VEGF receptor in dialysate for 24 hours
Key secondary outcomes 1. Cardiac function examined by echocardiography
2. Augmentation Index

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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who the peritoneal dialysis catheters were inserted
Key exclusion criteria 1. Patients aged less than 20 years
2. Patients not providing a written consent by themselves or their family members
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Tsuruya
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL 092-642-5843
Email tsuruya@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Nakano
Organization Kyushu University
Division name Kidney Care Unit
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL 092-642-5843
Homepage URL
Email toshink@med.kyushu-u.ac.jp

Sponsor
Institute Graduate School of Medical Sciences, Kyushu University, Department of Integrated Therapy for Chronic Kidney Disease
Institute
Department

Funding Source
Organization Graduate School of Medical Sciences, Kyushu University, Department of Integrated Therapy for Chronic Kidney Disease
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
2009 Year 09 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 Open public recruiting
Date of protocol fixation
2009 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2018 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Peritoneal membranes are resected when the peritoneal dialysis catheters are inserted and removed. The tests of blood, urine and dialysate are prospectively examined for every six months since beginning of peritoneal dialysis.

Management information
Registered date
2009 Year 09 Month 01 Day
Last modified on
2017 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002972

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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