UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021684
Receipt No. R000025010
Scientific Title LDLapheresis-mediated Endothelial activation Therapy to Severe-Peripheral Artery Disease study
Date of disclosure of the study information 2016/04/01
Last modified on 2017/09/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition conventional therapy-resistant peripheral artery disease (PAD)without hypercholesterolemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information YES

Objectives
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

Assessment
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]

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) KANEKA CORPORATION

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

Other administrative information
Date of disclosure of the study information
2016 Year 04 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 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
Other related information

Management information
Registered date
2016 Year 03 Month 30 Day
Last modified on
2017 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025010

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.