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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014124
Receipt No. R000016448
Official scientific title of the study The detection of moleclues that affect peritoneal function failure in peritoneal dialysis patients
Date of disclosure of the study information 2014/05/30
Last modified on 2016/08/10

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Basic information
Official scientific title of the study The detection of moleclues that affect peritoneal function failure in peritoneal dialysis patients
Title of the study (Brief title) The detection of moleclues that affect peritoneal function failure
Region
Japan

Condition
Condition peritoneal function failure to peritoneal dialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To detect the new molecules that affect peritoneal function failure to peritoneal dialysis in peritoneal dialysis patients.
Basic objectives2 Others
Basic objectives -Others To detect the new molecules that affect peritoneal function failure to peritoneal dialysis in peritoneal dialysis patients in their blood and peritoneal dialysis fluid.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The analysis of the associaton between the new molecluse and the rsults of peritoneal equilibration test.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The peritoneal dialysis patients
Key exclusion criteria The patinets who cannot understand informed consent.
Target sample size 500

Research contact person
Name of lead principal investigator Yoshiyuki Morishita
Organization Saitama Medical Center, Jichi Medical University
Division name Division of Nephrology, Department of Integrated Medicine
Address 1-847, Amanuma, Omiya-ku, Saitama-city, Saitama, 330-8503, Japan
TEL 0486472111
Email ymori@jichi.ac.jp

Public contact
Name of contact person Yoshiyuki Morishita
Organization Saitama Medical Center, Jichi Medical University
Division name Division of Nephrology, Department of Integrated Medicine
Address 1-847, Amanuma, Omiya-ku, Saitama-city, Saitama, 330-8503, Japan
TEL 0486472111
Homepage URL
Email ymori@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Jichi Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2014 Year 05 Month 30 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 12 Month 09 Day
Anticipated trial start date
2013 Year 12 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information The analysis of the associaton between the new molecluse and the rsults of peritoneal equilibration test.

Management information
Registered date
2014 Year 05 Month 30 Day
Last modified on
2016 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016448


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