UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010572 |
|---|---|
| Receipt number | R000001758 |
| Scientific Title | Clinical evaluation of matrix metalloproteinases as early diagnostic markers of peritoneal deterioration and encapsulating peritoneal sclerosis. |
| Date of disclosure of the study information | 2013/04/30 |
| Last modified on | 2014/05/30 13:22:06 |
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Basic information
Public title
Clinical evaluation of matrix metalloproteinases as early diagnostic markers of peritoneal deterioration and encapsulating peritoneal sclerosis.
Acronym
Multicenter analysis in Japan: original indicator of peritoneal deterioration (MAJOR-PD)
Scientific Title
Clinical evaluation of matrix metalloproteinases as early diagnostic markers of peritoneal deterioration and encapsulating peritoneal sclerosis.
Scientific Title:Acronym
Multicenter analysis in Japan: original indicator of peritoneal deterioration (MAJOR-PD)
Region
| Japan |
Condition
Condition
encapsulating peritoneal sclerosis (EPS)/ sclerosing encapsulating peritonitis(SEP)
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical evaluation of matrix metalloproteinase level in drained dialysate, mesothelial cell area or others as early diagnostic markers for encapsulating peritoneal sclerosis.
Basic objectives2
Others
Basic objectives -Others
efficacy as diagnostic marker.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical evaluation of matrix metalloproteinase level in drained dialysate, mesothelial cell area or others in encapsulating peritoneal sclerosis patients.
Key secondary outcomes
Clinical evaluation of correlation between peritoneal function and matrix metalloproteinase level in drained dialysate, mesothelial cell area or others in PD patients.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients treated with peritoneal dialysis.
Key exclusion criteria
patients infected with pathogenic organism or virus.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Kusano |
Organization
Jichi Medical University
Division name
Division of Nephrology, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke-city, Tochigi, 329-0498, Japan
TEL
0285-58-7346
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jichi Medical University
Division name
Division of Nephrology, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke-city, Tochigi, 329-0498, Japan
TEL
Homepage URL
Sponsor or person
Institute
Division of Nephrology, Department of Medicine, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Department of Medicine, Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shirasagi hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 04 | Month | 30 | 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
Completed
Date of protocol fixation
| 2004 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2013 | Year | 04 | Month | 23 | Day |
Last modified on
| 2014 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001758
