UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Study for the Immunoadsorption Therapy of Dilated Cardiomyopathy using AMT-0902-1: Prospective, Multicenter, Randomized, Self- and Parallel Group- Comparative Study to Evaluate the Efficacy and Safety.
Title of the study (Brief title)	Randomized, Self- and Parallel Group- Comparative Trial using Immunoadsorption Plasma-apheresis of Dilated Cardiomyopathy(RESCUE DCM)
Region	Japan

Condition
Condition	Dilated cardiomyopathy(DCM)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives are: to evaluate the efficacy of the investigational device by comparing the change in left ventricular ejection fraction(LVEF) before and after therapy when immunoadsorption therapy using AMT-0902-1 is performed in patients with dilated cardiomyopathy(DCM); to compare the change in LVEF between treated and non-treated patients in a group of patients who receive the same therapy 3 months late(delay group); to analyze the change in LVEF by different antimyocardial autoantibodies and patient background characteristics; to examine the clinical subjective and objective symptoms of the subjects; and to examine the safety of AMT-0902-1.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	LVEF change (by RI) within 3 months after the treatment
Key secondary outcomes	1) Comparison of LVEF (by RI) between immunoadsorption group and delay group at 3 months from baseline 2) Comparison of LVEF (by RI) between immunoadsorption group and delay group at 6 months from baseline 3) LVEF by echocardiography, Analysis of the primary outcome and 1) and 2) of secondary outcome 4) Cardiac events up to 12 months 5) Analysis of subgroup (antimyocardial autoantibody, subject demographics) 6) Evaluation of 6-minute walk test, cardiothoracic ratio, cardiopulmonary exercise testing, BNP and ANP 7) Evaluation of NYHA classification and QOL questionnaire (with specific activity scale: SAS) 8) Overall evaluation of echocardiography 9) Evaluation of safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Immunoadsorption group: After the examination at the start is completed, 5 sessions of immunoadsorption therapy using AMT-0902-1 will be performed in 2 weeks (first treatment stage). Three months after the start, five sessions of immunoadsorption therapy will be again performed in 2 weeks (second treatment stage). A total of 10 sessions will be performed.
Interventions/Control_2	Delay group: After the examination at the start is completed, subjects in the delay group will be hospitalized for 2 weeks without immunoadsorption therapy using AMT-0902-1 (non-treatment stage). Three months after the start, 5 sessions of immunoadsorption therapy will be performed in 2 weeks (first treatment stage). A total of 5 sessions will be performed.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Idiopathic DCM (diagnosed following the "Guide and Explanation of Diagnosis of Cardiomyopathy) *Exclude Specified myocardial disease (Secondary myocardial disease) below 1) Ischemic myocardial disease 2) Valvular myocardial disease 3) Hypertensive myocardial disease 4) Inflammatory myocardial disease 5) Metabolic myocardial disease 6) Systemic myocardial disease 7) Muscular dystrophy 8) Nervous/Muscular disease 9) Hypersensitivity/Toxic disease 10) Postpartal cardiomyopathy (2) NYHA (New York Heart Association) class III-IV (3) LVEF < 30% measured by RI or LVEF < 35% measured by echocardiography in the past 3 months(12 weeks) (4) Being resistant to standard therapy with ACE inhibitors or ARB, b-blocker and Aldosterone antagonists for heart failure for at least 3 months prior to screening date. (5) 18 years-old or older (6) Male or female patients (7) Inpatients or outpatients
Key exclusion criteria	(1) Secondary DCM resulting from other diseases(e.g.hypertrophic or restrictive cardiomypathy) (2)Left ventricular noncompaction (3)Implanted with left ventricular assist device(LVAD) (4)Received Cardiac resynchronization therapy(CRT or CRT-D) in the past 6 months (5) Received Heart transplantation (6) Patients on an ACE inhibitor, which cannot be switched to an ARB (7)Weight <40kg (8)Platelet number <100,000/mm3 (9)Leukocyte number <3,000/mm3 (10)Anemia(hemoglobin <10 g/dL) (11)History of shock during extracorporeal circulation treatments (12) Impaired renal function (serum creatinine level >3 mg/dl) Impaired hepatic function (AST(GOT) or ALT(GPT) >2.5 times the upper limit of normal or >100 IU/L) (13) Being treated for a malignant tumor (14) Pregnant or potentially pregnant women or women who desire to become pregnant during the study period (15) Infected, or suspected to be infected, with HBV, HCV, or HIV (16) Patients who have difficulty understanding the informed consent document (17) Participation in any other clinical study within 26 weeks(182 days) before providing their informed consent (18) Previous treatments for DCM with AMT-0902-1 (19) Considered inappropriate for the clinical study by an investigator or subinvestigator
Target sample size	40

Research contact person
Name of lead principal investigator	Hitonobu Tomoike
Organization	Sakakibara Heart Institute
Division name	Director of the Hospital
Address	3-16-1, Asahi-cho, Fuchu, Tokyo 183-0003 JAPAN
TEL
Email

Public contact
Name of contact person	Yoichi Kato
Organization	ASAHIKASEI KURAREY MEDICAL CO., LTD.
Division name	Clinical Development Center
Address	1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo 101-8101, Japan
TEL	03-3296-3787
Homepage URL
Email

Sponsor
Institute	ASAHIKASEI KURAREY MEDICAL CO., LTD.
Institute
Department

Funding Source
Organization	ASAHIKASEI KURAREY MEDICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

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

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW	初回届出年月日　昭和62年6月22日、　届出回数　2回

Institutions
Institutions	国立循環器病研究センター（大阪府） 慶應義塾大学病院（東京都） 学校法人北里研究所北里大学北里研究所病院（東京都） 学校法人北里研究所北里大学病院（神奈川県） 独立行政法人国立病院機構大阪医療センター（大阪府） 名古屋第二赤十字病院（愛知県） 東京大学医学部附属病院（東京都） 自治医科大学附属さいたま医療センター（埼玉県） 国家公務員共済組合連合会虎の門病院（東京都） 財団法人日本心臓血圧研究振興会附属榊原記念病院（東京都）

Other administrative information
Date of disclosure of the study information	2010 Year 01 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 11 Month 17 Day
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2012 Year 11 Month 01 Day
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	2010 Year 01 Month 27 Day
Last modified on	2019 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003727