UMIN-CTR Clinical Trial

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

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

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

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.)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Kaneka Medix Co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2014

Year

08

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2014

Year

08

Month

05

Day

Last modified on

2016

Year

12

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017160