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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003106
Receipt No. R000003727
Scientific Title 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.
Date of disclosure of the study information 2010/01/29
Last modified on 2019/02/07

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Basic information
Public title 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.
Acronym Randomized, Self- and Parallel Group- Comparative Trial using Immunoadsorption Plasma-apheresis of Dilated Cardiomyopathy(RESCUE DCM)
Scientific Title 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hitonobu Tomoike
Organization Sakakibara Heart Institute
Division name Director of the Hospital
Zip code
Address 3-16-1, Asahi-cho, Fuchu, Tokyo 183-0003 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Kato
Organization ASAHIKASEI KURAREY MEDICAL CO., LTD.
Division name Clinical Development Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2009 Year 11 Month 17 Day
Date of IRB
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

Other
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

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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