UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020830 |
|---|---|
| Receipt number | 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 08:34:13 |
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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
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
dm15025u@st.kitasato-u.ac.jp
Sponsor or person
Institute
Graduate school of medical sciences, kitasato university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023992
