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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010572
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Division of Nephrology, Department of Medicine, Jichi Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001758

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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