UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Asymptomatic Peripheral Arterial Disease and Mortality in Patients on Hemodialysis
Title of the study (Brief title)	Asymptomatic Peripheral Arterial Disease and Mortality in Patients on Hemodialysis
Region	Japan

Condition
Condition	Patients who undergo maintenance hemodialysis
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effect of asymptomatic PAD on the risk of mortality in patients undergoing HD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	All-cause mortality
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients were undergoing maintenance hemodialysis therapy and agreed to participate in the follow-up study
Key exclusion criteria	Patients who had an ABI >0.99 with lower extremity peripheral revascularization and amputation resulting from PAD
Target sample size	310

Research contact person
Name of lead principal investigator	Atsuhiko Matsunaga
Organization	Graduate school of medical sciences, kitasato university
Division name	Department of rehabilitation sciences
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa 252-0373, Japan
TEL	042-778-9970
Email	atsuhikonet@gmail.com

Public contact
Name of contact person	Manae Harada
Organization	Graduate school of medical sciences, kitasato university
Division name	Department of rehabilitation sciences
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa 252-0373, Japan
TEL	042-778-9081
Homepage URL
Email	dm15025u@st.kitasato-u.ac.jp

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	Sagami Circulatory Organ Clinic
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	2016 Year 02 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 05 Month 01 Day
Anticipated trial start date	2012 Year 05 Month 08 Day
Last follow-up date	2015 Year 07 Month 01 Day
Date of closure to data entry	2015 Year 08 Month 01 Day
Date trial data considered complete	2015 Year 10 Month 01 Day
Date analysis concluded	2015 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Retrospective Cohort Study

Management information
Registered date	2016 Year 02 Month 01 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023992