UMIN-CTR Clinical Trial

Basic information
Public title	Factors Determining Long-Term Prognosis among Patients on Hemodialysis
Acronym	Factors Determining Long-Term Prognosis among Patients on Hemodialysis
Scientific Title	Factors Determining Long-Term Prognosis among Patients on Hemodialysis
Scientific Title:Acronym	Factors Determining Long-Term Prognosis among Patients on Hemodialysis
Region	Japan

Condition
Condition	Patients undergoing hemodialysis
Classification by specialty	Cardiology Nephrology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether low physical function and low physical activity increases the risk of cardiovascular events or death.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	All cause-mortality and cardiovascular hospitalizations
Key secondary outcomes	Physical function, Physical activity, Cognitive function, Depressive symptoms, ADL performance, and QOL

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Outpatients with chronic kidney disease undergoing maintenance hemodialysis therapy at 3 times a week
Key exclusion criteria	1)Cognitive dysfunction 2)Significant myocardial ischemia during low-intensity exercise 3)Presence of a recent hospitalization (< 3 month) 4)Ongoing severe arrhythmia 5)Patients with inadequate oxygenation 6)Patients with uncontrolled diabetes 7)Recent cardiovascular events
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Atsuhiko Middle name Last name Matsunaga
Organization	Kitasato University Graduate School
Division name	Medical Sciences
Zip code	252-0373
Address	1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL	042-778-9970
Email	atsuhikonet@gmail.com

Public contact
Name of contact person	1st name Atsuhiko Middle name Last name Matsunaga
Organization	Kitasato University Graduate School
Division name	Medical Sciences
Zip code	252-0373
Address	1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL	042-778-9970
Homepage URL
Email	atsuhikonet@gmail.com

Sponsor
Institute	Graduate School of Medical Sciences, Kitasato University
Institute
Department

Funding Source
Organization	Graduate School of Medical Sciences, Kitasato University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Dialysis facilities cooperated with Kitasato University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	School of Allied Health Sciences, Kitasato University
Address	1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
Tel	042-778-8896
Email	inouek@kitasato-u.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	北里大学と連携した透析クリニック (神奈川県、東京都、兵庫県など)

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 26 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	Enrolling by invitation
Date of protocol fixation	2002 Year 10 Month 01 Day
Date of IRB	2002 Year 10 Month 01 Day
Anticipated trial start date	2002 Year 10 Month 01 Day
Last follow-up date	2031 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	After the baseline survey, prospective observation will be conducted, and physical function are evaluated at regular intervals (approximately one year).

Management information
Registered date	2021 Year 11 Month 26 Day
Last modified on	2021 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052620