UMIN-CTR Clinical Trial

Basic information
Public title	the relationship between physical function and adverse event in elderly patients undergoing peritoneal dialysis: a prospective cohort study.
Acronym	the relationship between physical function and adverse event in elderly patients undergoing peritoneal dialysis: a prospective cohort study.
Scientific Title	the relationship between physical function and adverse event in elderly patients undergoing peritoneal dialysis: a prospective cohort study.
Scientific Title:Acronym	the relationship between physical function and adverse event in elderly patients undergoing peritoneal dialysis: a prospective cohort study.
Region	Japan

Condition
Condition	chronic kidney disease
Classification by specialty	Nephrology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to assess the physical function in elderly PD patients and investigate association between physical function and prognosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall mortality
Key secondary outcomes	Cardiovascular event, peritonitis, hospitalization, Withdrawal of peritoneal dialysis

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	65 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	patients undergoing peritoneal dialysis Patients with written informed consent after receiving a full explanation Patients without apparent dementia
Key exclusion criteria	patient with hemodialysis patient with renal transplant Patient judged to be inappropriate by the charge doctor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Yabe
Organization	Seirei christopher university
Division name	Department of Rehabilitation
Zip code	433-8558
Address	3453 Mikatahara, Kita-ku, Hamamatsu, Shizuoka.
TEL	0534391400
Email	yabe0909@gmail.com

Public contact
Name of contact person	1st name Yabe Middle name Last name Hiroki
Organization	Seirei christopher university
Division name	Department of Rehabilitation
Zip code	433-8558
Address	3453 Mikatahara, Kita-ku, Hamamatsu, Shizuoka.
TEL	0534391400
Homepage URL
Email	yabe0909@gmail.com

Sponsor
Institute	Nagoya Kyoritsu Hospital
Institute
Department

Funding Source
Organization	japan society for the promoting of science
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Seirei Christopher University
Address	3453 Mikatahara, kita-ku Hamamatsu, Shizuoka
Tel	0534391400
Email	yabe0909@gmail.com

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	名古屋共立病院(愛知県)

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 29 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	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 01 Day
Date of IRB	2017 Year 02 Month 07 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 11 Month 30 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2022 Year 04 Month 30 Day

Other
Other related information	observation of adverse events in regular outpatient clinics

Management information
Registered date	2019 Year 10 Month 28 Day
Last modified on	2022 Year 05 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043767