UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Low Density Lipoprotein adsorption treatment on Arteriosclerosis obliterates(ASO)
Title of the study (Brief title)	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.)

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

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	Shigeo Negi
Organization	WAKAYAMA MEDICAL UNIVERSITY
Division name	Division of Nephrology, Department of Internal Medicine
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	Shigeo Negi
Organization	WAKAYAMA MEDICAL UNIVERSITY
Division name	Division of Nephrology, Department of Internal Medicine
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

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 12 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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