UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000652 |
|---|---|
| Receipt number | 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 15:40:19 |
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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
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/
uchinok@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000783
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