Cholesterol EmbolismPhase 2NCT01726868
Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
A Phase 2 study testing Liposorber LA-15 System in people with Cholesterol Embolism, run by Japan Community Health Care Organization Sendai Hospital at 1 site in Japan.
Trial summary
The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cholesterol Embolism
- What is being tested?
- Liposorber LA-15 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2013to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet all of the following criteria.
- Patients who had cardiac catheterization or vascular surgery in the last 24 weeks before the time of obtaining informed consent.
- Patients who satisfy all of the following criteria or are diagnosed as CCE by skin or renal biopsy.
- Patients with progressive renal dysfunction in the course of weeks or months.
- Patients with skin lesions such as livedo reticularis of lower extremities or blue toe syndrome.
- Eosinophil count is more than 400 per microliter.
- Patients who or patients whose legal representative understood the requirements of the study and signed the informed consent forms.
Who cannot join
- Patients who meet any of the following criteria will be excluded.
- Patients with contraindication to anticoagulant (Nafamostat Mesilate).
- Blood purification therapy is inapplicable because of severe heart failure, acute myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable hypertension or hypotension.
- Patients with body weight less than 40kg.
- Patients with a history of allergic reaction or hypersensitivity to blood purification.
- Patients who cannot stop taking ACE inhibitors.
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- Patients with any disease in which corticosteroid, statin are contraindicated.
- Patients participated in another clinical trial or study at the time of obtaining informed consent.
- Patients receiving chronic hemodialysis.
- Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
Toshinobu Sato, MD, PhD contact
Japan1 site, 1 recruiting
- Recruiting
Sendai Shakaihoken Hospital
Sendai, Miyagi, 981-8501
Toshinobu Sato, MD, PhD, +81-22-275-3111
About this study
The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.
- Conditions
- Cholesterol Embolism
- Being tested
- Liposorber LA-15 System
- Medical subject headings
- Embolism, Cholesterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposorber LA-15 SystemDevice
Six sessions of blood purification treatment with Liposorber LA-15 System.
| Study group | Role | What they receive |
|---|---|---|
| Liposorber LA-15 System | Experimental | Not described Receives: Device: Liposorber LA-15 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic hemodialysis
Measured: Six months
Secondary outcomes (6)
Dose of drugs
Measured: Six months
Incidence of lower limb amputation
Measured: Six months
Incidence of gangrene
Measured: Six months
Incidence of multi organ failure
Measured: Six months
Survival rate
Measured: Six months
Incidence of adverse events
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startJul 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholesterol EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japan Community Health Care Organization Sendai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOSHINOBU SATO, Japan Community Health Care Organization Sendai Hospital
- Investigators
- Toshinobu Sato, MD, PhD, Study director, Japan Community Health Care Organization Sendai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726868
- Sponsor's protocol ID
- CCE-001
- Status last verified
- Jun 2016
- First submitted
- 10 Nov 2012
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ishiyama K, Sato T. Efficacy of LDL apheresis for the treatment of cholesterol crystal embolism: A prospective, controlled study. Ther Apher Dial. 2022 Apr;26(2):456-464. doi: 10.1111/1744-9987.13706. Epub 2021 Jul 11.
PubMed 34216189
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
- ClinicalTrials.gov ID
- NCT01726868
- Acronym / sponsor ID
- CCE-001
- Conditions
- Cholesterol Embolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Japan Community Health Care Organization Sendai HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposorber LA-15 System | Experimental | Device: Liposorber LA-15 System |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who meet all of the following criteria.
- Patients who had cardiac catheterization or vascular surgery in the last 24 weeks before the time of obtaining informed consent.
- Patients who satisfy all of the following criteria or are diagnosed as CCE by skin or renal biopsy.
- Patients who or patients whose legal representative understood the requirements of the study and signed the informed consent forms.
Key exclusion criteria (10 listed)
- Patients who meet any of the following criteria will be excluded.
- Patients with contraindication to anticoagulant (Nafamostat Mesilate).
- Blood purification therapy is inapplicable because of severe heart failure, acute myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable hypertension or hypotension.
- Patients with body weight less than 40kg.
- Patients with a history of allergic reaction or hypersensitivity to blood purification.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposorber LA-15 SystemSix sessions of blood purification treatment with Liposorber LA-15 System. | Device | Liposorber LA-15 System |
Primary outcome
Incidence of chronic hemodialysis
Time frame: Six months
6 secondary outcomes
Dose of drugs
Time frame: Six months
Incidence of lower limb amputation
Time frame: Six months
Incidence of gangrene
Time frame: Six months
Incidence of multi organ failure
Time frame: Six months
Survival rate
Time frame: Six months
Incidence of adverse events
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
- Derived from this study: PubMed 34216189Ishiyama K, Sato T. Efficacy of LDL apheresis for the treatment of cholesterol crystal embolism: A prospective, controlled study. Ther Apher Dial. 2022 Apr;26(2):456-464. doi: 10.1111/1744-9987.13706. Epub 2021 Jul 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshinobu Sato, MD, PhD contact
Toshinobu Sato, MD, PhD study director
Japan Community Health Care Organization Sendai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposorber LA-15 System in people with Cholesterol Embolism, run by Japan Community Health Care Organization Sendai Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Toshinobu Sato, MD, PhD (+81-22-275-3111), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chronic hemodialysis (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01726868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.