UMIN-CTR Clinical Trial

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 Toshiaki Middle name Last name Nakano
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Clinical Science
Zip code	812-8582
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL	092-642-5843
Email	toshink@med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Toshiaki Middle name Last name Nakano
Organization	Kyushu University
Division name	Kidney Care Unit
Zip code	812-8582
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 Medicine and Clinical Science
Institute
Department

Funding Source
Organization	Graduate School of Medical Sciences, Kyushu University, Department of Medicine and Clinical Science
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	Kyushu University, IRB
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka
Tel	092-642-6772
Email	ijkseimei@jimu.kyushu-u.ac.jp

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	2009 Year 07 Month 24 Day
Anticipated trial start date	2009 Year 08 Month 01 Day
Last follow-up date	2022 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	2021 Year 03 Month 11 Day

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