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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000652
Receipt No. R000000783
Scientific Title Effects of Low Density Lipoprotein Apheresis on Oxidative Stress and Endothelial/Vascular Smooth Muscle Cell Function in Patients with Peripheral Arterial Disease and End-stage Renal Disease
Date of disclosure of the study information 2008/11/01
Last modified on 2015/11/10

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Basic information
Public title Effects of Low Density Lipoprotein Apheresis on Oxidative Stress and Endothelial/Vascular Smooth Muscle Cell Function in Patients with Peripheral Arterial Disease and End-stage Renal Disease
Acronym Effects of LDL apheresis on ESRD patients with PAD
Scientific Title Effects of Low Density Lipoprotein Apheresis on Oxidative Stress and Endothelial/Vascular Smooth Muscle Cell Function in Patients with Peripheral Arterial Disease and End-stage Renal Disease
Scientific Title:Acronym Effects of LDL apheresis on ESRD patients with PAD
Region
Japan

Condition
Condition peripheral artery disease, end-stage renal disease on hemodialysis
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will be performed to examine the effects of LDL apheresis on cellular functions of commercially available human vescular endothelial and smooth muscle cells using serum from patients before and after LDL apheresis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Clinical papameters
1) Signs & symptoms (pain at rest, intermittent claudication, walking distance)
2) Blood biochemistry (serum lipid including total cholesterol and LDL, coaglatory factors including fibrinogen, CRP, oxidised LDL, MDA-LDL, AGE, VEGF, HGF).
3) ABI/baPWV
2. Vascular cell functions
1) Human vascular endothelial cells (commercially available) (ecNOS expression, proliferative activity, tube formation activity)
2) Human vascular smooth muscle cells (commercially available)(expressions of AT1 receptor and its interacting molecule ATRAP, growth factors, extracellular matrix, proliferation activity).
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 The ESRD patients on hemodialysis who fulfilled the following criteria:
1. Ages from 20 to 80 years old,
2. Classified as > Fontaine class II,
3. Resistant to medication and/or difficult to perform PTA and/or bypass surgery.
Key exclusion criteria Exclusion criteria:
1. Poor controlled diabetics,
2. Poor controlled hypertensives,
3. Moderate to severe liver dysfunction,
4. Judged as unsuitable from other reasons.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi TAMURA
Organization Yokohama City University School of Medicine
Division name Department of Cardiorenal Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2635
Email tamukou@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuaki Uchino
Organization Yokohama City University School of Medicine
Division name Department of Cardiorenal Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2635
Homepage URL http://www-user.yokohama-cu.ac.jp/
Email uchinok@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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 横浜市立大学附属病院
Yokohama City University Hospital

Other administrative information
Date of disclosure of the study information
2008 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/23551675
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 Main results already published
Date of protocol fixation
2007 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 10 Month 01 Day
Date analysis concluded
2014 Year 09 Month 01 Day

Other
Other related information 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. In this study, we will examine a possible relationship between clinical parameters including walking distance and ABI score and vasular endotherial and smooth muscle cell functions in terms of oxidative stress and coagulatory and inflammatory markers. For this purpose we will use the patients' serum before and after the therapy of LDL apheresis to stimulate human vascular cells which are commercially available cells. Our hypothesis is LDL apheresis can improve human vascular endothelial cell function and inhibit human vascular smooth muscle cell function through inhibition of oxidative stress and inflammatory response, especially in LDL apheresis-responder patients.

Management information
Registered date
2007 Year 03 Month 23 Day
Last modified on
2015 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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