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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033076
Receipt No. R000037713
Scientific Title The relationship between the time course of peritoneal function and adipocytokine
Date of disclosure of the study information 2018/06/21
Last modified on 2018/06/21

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Basic information
Public title The relationship between the time course of peritoneal function and adipocytokine
Acronym The relationship between the time course of peritoneal function and adipocytokine
Scientific Title The relationship between the time course of peritoneal function and adipocytokine
Scientific Title:Acronym The relationship between the time course of peritoneal function and adipocytokine
Region
Japan

Condition
Condition Chronic Kidney Disease Stage G5D
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure the serum adipocytokines of PD patients and investigate the correlation between serum LDL value and change in peritoneal function by Peritoneal Equilibration Test (PET). We also analyze the correlation between various parameters at the time of PD induction. Also, we clarify whether these adipocytokines are predictors of PD duration. Furthermore, these adipocytokines predict maintenance of peritoneal function and clarify whether it can be an indicator of appropriate PD treatment.
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between peritoneal function and adipocytokine.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Correlation with adiponectin, leptin and apelin levels and rate of change of D / P ratio and D / D0 ratio over 6 months.
Key secondary outcomes

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
85 years-old >=
Gender Male and Female
Key inclusion criteria Peritoneal Dialysis Patients
Key exclusion criteria Combination therapy with hemodialysis and peritoneal dialysis
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukinao Sakai
Organization Nippon Medical School
Division name Department of Nephrology
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 JAPAN
TEL 03-3822-2131
Email y-sakai@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukinao Sakai
Organization Nippon Medical School
Division name Department of Nephrology
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 JAPAN
TEL 03-3822-2131
Homepage URL
Email y-sakai@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Nippon Medical School
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
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
2018 Year 06 Month 21 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
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 06 Month 21 Day
Last modified on
2018 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037713

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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