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
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
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
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
