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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009306
Receipt No. R000010406
Scientific Title Clinical study to evaluate the efficacy of blood purification therapy on cholesterol crystal embolism
Date of disclosure of the study information 2012/11/11
Last modified on 2017/08/30

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Basic information
Public title Clinical study to evaluate the efficacy of blood purification therapy on cholesterol crystal embolism
Acronym Clinical evaluation of blood purification therapy on CCE
Scientific Title Clinical study to evaluate the efficacy of blood purification therapy on cholesterol crystal embolism
Scientific Title:Acronym Clinical evaluation of blood purification therapy on CCE
Region
Japan

Condition
Condition cholesterol crystal embolism
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of chronic hemodialysis
Key secondary outcomes Dose of drugs
Incidence of lower limb amputation
Incidence of gangrene
Incidence of multi organ failure
Survival rate
Incidence of adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Six sessions of blood purification treatment with Liposorber LA-15 System.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria.
(i) Patients who had cardiac catheterization or vascular surgery in the last 24 weeks before the time of obtaining informed consent.
(ii) Patients who satisfy all of the following criteria or are diagnosed as CCE by skin or renal biopsy.
a. Patients with progressive renal dysfunction in the course of weeks or months.
b. Patients with skin lesions such as livedo reticularis of lower extremities or blue toe syndrome.
c. Eosinophil count is more than 400 per microliter.
(iii) Patients who or patients whose legal representative understood the requirements of the study and signed the informed consent forms.
Key exclusion criteria Patients who meet any of the following criteria will be excluded.
(i) Patients with contraindication to anticoagulant (Nafamostat Mesilate).
(ii) Blood purification therapy is inapplicable because of severe heart failure, acute myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable hypertension or hypotension.
(iii) Patients with body weight less than 40kg.
(iv) Patients with a history of allergic reaction or hypersensitivity to blood purification therapy.
(v) Patients who cannot stop taking ACE inhibitors.
(vi) Patients with any disease in which corticosteroid, statin are contraindicated.
(vii) Patients participated in another clinical trial or study at the time of obtaining informed consent.
(viii) Patients receiving chronic hemodialysis.
(ix) Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
Target sample size 35

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshinobu Sato
Organization Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Division name Department of Nephrology
Zip code
Address 3-16-1 Tsutsumimachi, Aoba-ku, Sendai, Miyagi 981-8501, Japan.
TEL 022-275-3111
Email sato-toshinobu@sendai.jcho.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toshinobu Sato
Organization Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Division name Department of Nephrology
Zip code
Address 3-16-1 Tsutsumimachi, Aoba-ku, Sendai, Miyagi 981-8501, Japan.
TEL 022-275-3111
Homepage URL
Email sato-toshinobu@sendai.jcho.go.jp

Sponsor
Institute Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Institute
Department

Funding Source
Organization Miyagi Kidney Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01726868
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 独立行政法人地域医療機能推進機構仙台病院(宮城県)(Japan Community Health care Organization Sendai Hospital)
筑波大学附属病院(茨城県)(University of Tsukuba Hospital)
小倉記念病院(福岡県)(Kokura Memorial Hospital)
三重大学医学部附属病院(三重県)(Mie University Hospital)
順天堂大学医学部附属順天堂医院(東京都)(Juntendo University Hospital)
富山県立中央病院(富山県)(Toyama Prefectural Central Hospital)
公立松任石川中央病院(石川県)(Public Central Hospital of Matto Ishikawa)
信州大学医学部附属病院(長野県)(Shinshu University Hospital)
杏林大学医学部付属病院(東京都)(Kyorin University Hospital)
島根大学医学部附属病院(島根県)(Shimane University Hospital)
帝京大学医学部附属病院(東京都)(Teikyo University Hospital)
藤田保健衛生大学病院(愛知県)(Fujita Health University Hospital)
自治医科大学附属さいたま医療センター(埼玉県)(Saitama Medical Center Jichi Medical University)
国立大学法人金沢大学附属病院(石川県)(Kanazawa University Hospital)








Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 11 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 Enrolling by invitation
Date of protocol fixation
2012 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 07 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
2012 Year 11 Month 10 Day
Last modified on
2017 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010406

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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