UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020830
Receipt No. R000023992
Scientific Title Asymptomatic Peripheral Arterial Disease and Mortality in Patients on Hemodialysis
Date of disclosure of the study information 2016/02/01
Last modified on 2019/03/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Asymptomatic Peripheral Arterial Disease and Mortality in Patients on Hemodialysis
Acronym Asymptomatic Peripheral Arterial Disease and Mortality in Patients on Hemodialysis
Scientific Title Asymptomatic Peripheral Arterial Disease and Mortality in Patients on Hemodialysis
Scientific Title:Acronym 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
1st name
Middle name
Last name Atsuhiko Matsunaga
Organization Graduate school of medical sciences, kitasato university
Division name Department of rehabilitation sciences
Zip code
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
1st name
Middle name
Last name Manae Harada
Organization Graduate school of medical sciences, kitasato university
Division name Department of rehabilitation sciences
Zip code
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)

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
2016 Year 02 Month 01 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 Main results already published
Date of protocol fixation
2012 Year 05 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023992

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.