UMIN-CTR Clinical Trial

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 Yukinao Middle name Last name Sakai
Organization	Nippon Medical School
Division name	Department of Nephrology
Zip code	113-8603
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 Yukinao Middle name Last name Sakai
Organization	Nippon Medical School
Division name	Department of Nephrology
Zip code	113-8603
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	Ethics Committee of Noppon Medical School Hospital
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 JAPAN
Tel	03-3822-2131
Email	nms_fuzokurinri@nms.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	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	Completed
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 03 Month 28 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
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	2020 Year 07 Month 09 Day

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