UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to evaluate the efficacy of blood purification therapy on cholesterol crystal embolism
Title of the study (Brief title)	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
Name of lead principal investigator	Toshinobu Sato
Organization	Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Division name	Department of Nephrology
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
Name of contact person	Toshinobu Sato
Organization	Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Division name	Department of Nephrology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 09 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010406