UMIN-CTR Clinical Trial

Public title

LDLapheresis-mediated Endothelial activation Therapy to Severe-Peripheral Artery Disease study

Acronym

LDLapheresis-mediated Endothelial activation Therapy to Severe-Peripheral Artery Disease study(LETS-PAD study)

Scientific Title

LDLapheresis-mediated Endothelial activation Therapy to Severe-Peripheral Artery Disease study

Scientific Title:Acronym

LDLapheresis-mediated Endothelial activation Therapy to Severe-Peripheral Artery Disease study(LETS-PAD study)

Region

Japan

Condition

conventional therapy-resistant peripheral artery disease (PAD)without hypercholesterolemia

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To evaluate the efficacy of low-density lipoprotein apheresis in patients with conventional therapy-resistant PAD without hypercholesterolemia

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

The followings are examined at baseline and one month after 10th apheresis:
1)ankle brachial pressure index
2)Vascular Quality of Life Questionnaire scores

Key secondary outcomes

The followings are examined at baseline, one month after 10th apheresis, and three months after 10th apheresis:

[clinical examination]
(A)objective clinical symptoms
(a)walking distance
(b)leg ulcers
(B)subjective clinical symptoms
(a)Vascular Quality of Life Questionnaire
(b)leg pain in rest
(C)blood examinations
(a)serum lipids
(b)coagulatory/ inflammatory markers
(c)oxidative stress markers
(D)gene expression analysis in peripheral white blood cells

[physical examination]
(a)pulse wave velocity
(b)central blood pressure
(c)cardio-ankle vascular index
(d)endothelium function (reactive hyperemia peripheral arterial tonometry)
(e)skin perfusion pressure
(f)leg CT angiography (or leg MRA)
(g)ankle brachial pressure index

[the presence or absence of lower extremity amputation]

[the change in Fontaine classification]

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 apheresis is performed once or twice a week for three months (a total of 10 sessions are conducted).

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)age between 20 and 80
(2)patients diagnosed as peripheral artery disease
(3)Fontaine classification >=IIB
(4)ankle brachial pressure index <0.7
(5)serum total cholesterol<=220mg/dl and LDL cholesterol<=140mg/dl
(6)PAD refractory to conventional therapy such as percutaneous transluminal angioplasty or bypass graft surgery
(7)PAD resistant to the ameliorations of atherosclerotic risk factors including medication
(8)patients with written informed consent

Key exclusion criteria

(1)uncontrolled diabetes despite insulin therapy
(2)severe hepatic disorders
(3)inevitable use of ACE inhibitors during the treatment period
(4)ineligible patients judged by physicians

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiyuki Toya

Organization

Yokohama City University Hospital

Division name

Hemodialysis and Apheresis Center

Zip code

Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2635

Email

ystoya@yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Kouichi Tamura

Organization

Yokohama City University Hospital

Division name

Department of Medical Science and Cardiorenal Medicine

Zip code

Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2635

Homepage URL

Email

tamukou@yokohama-cu.ac.jp

Institute

Yokohama City University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

KANEKA CORPORATION

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

Date of disclosure of the study information

2016

Year

04

Month

01

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

2012

Year

05

Month

11

Day

Date of IRB

Anticipated trial start date

2016

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

03

Month

30

Day

Last modified on

2017

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025010