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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014762
Receipt No. R000017160
Scientific Title Effects of Low Density Lipoprotein adsorption treatment on Arteriosclerosis obliterates(ASO)
Date of disclosure of the study information 2014/08/11
Last modified on 2016/12/17

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Basic information
Public title Effects of Low Density Lipoprotein adsorption treatment on Arteriosclerosis obliterates(ASO)
Acronym Effects of LDL adsorption treatment on ASO
Scientific Title Effects of Low Density Lipoprotein adsorption treatment on Arteriosclerosis obliterates(ASO)
Scientific Title:Acronym Effects of LDL adsorption treatment on ASO
Region
Japan

Condition
Condition Peripheral artery disease, Arteriosclerosis obliterans, End-stage renal disease on hemodialysis
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will be performed to examine the effects of LDL adsorption treatment on ASO. The blood-flow improvement will evaluate with skin perfusion pressure (SPP) and the removal of risk factor will estimate using the remnant-like lipoprotein cholesterol in the ASO patient.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Signs , symptoms (wound healing, Fontaine classification, dose reduction of analgesics, intermittent claudication)
2. Blood flow (ABI, baPWV, SPP/lying position and sitting position)
Key secondary outcomes 1. Serum lipid (total cholesterol, HDL, triglyceride, remnant-like lipoprotein choresterol).
2. Blood test ( number of blood cells, CRP, HbA1c etc.)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 LDL adsorption treatment
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The ESRD patients on hemodialysis who fulfilled the following criteria:
1. Ages from 20 years old,
2. Classified as > Fontaine class II,
3. Resistant to medication and/or difficult to perform PTA and/or bypass surgery.
4. The SPP value of one of measured regions is below 50 mmHg.
Key exclusion criteria Exclusion criteria:
1. Who cannot interrupt an angiotensin converting enzyme inhibitor.
2.Judged as unsuitable from other reasons.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Negi
Organization WAKAYAMA MEDICAL UNIVERSITY
Division name Division of Nephrology, Department of Internal Medicine
Zip code
Address 811-1 Kimiidera, Wakayama-city, Wakayama 641-8510, JAPAN
TEL 073-441-0639
Email shigeon@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Negi
Organization WAKAYAMA MEDICAL UNIVERSITY
Division name Division of Nephrology, Department of Internal Medicine
Zip code
Address 811-1 Kimiidera, Wakayama-city, Wakayama 641-8510, JAPAN
TEL 073-441-0639
Homepage URL
Email shigeon@wakayama-med.ac.jp

Sponsor
Institute Division of Nephrology, Department of Internal Medicine , WAKAYAMA MEDICAL UNIVERSITY
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kaneka Medix Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 石本病院、宇治田循環器科内科、オリオン、河西田村病院、要外科・内科第二クリニック、上富田クリニック、きたクリニック、紀泉KDクリニック、紀ノ川クリニック、恵友病院、国保日高総合病院、児玉病院、済生会和歌山病院、桜ヶ丘病院、嶋病院、社会保険紀南病院、新宮市立医療センター、泉北藤井病院、高石藤井病院、玉置病院、谷口病院、津久野藤井クリニック、南紀新庄クリニック、西岡病院、西和歌山病院、半羽胃腸病院、藤井診療所、藤井病院、ましょうクリニック、まろクリニック、りんくう総合医療センター、和歌浦中央病院、和歌山県立医科大学、和歌山生協病院

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 11 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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information ASO is used almost synonymous with PAD (peripheral artery disease) now, and internationally, a term PAD is more common.

Accumulated evidence has demonstrated that LDL apheresis is effective for improvement of signs and symptoms of patients with peripheral artery disease. In ESRD patients, it is known that atherosclerotic vascular damage is more advanced than in patients with normal renal function and peripheral artery disease is usually complicated and resistant to midical therapy and vascular intervention including PTA and bypass surgery.

Management information
Registered date
2014 Year 08 Month 05 Day
Last modified on
2016 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017160


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