UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002429
Receipt number 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 2021/03/11 10:54:36

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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 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 or person

Institute

Graduate School of Medical Sciences, Kyushu University, Department of Medicine and Clinical Science

Institute

Department

Personal name



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

Value
https://center6.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