UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003106 |
|---|---|
| Receipt number | 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 18:08:51 |
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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
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
Sponsor or person
Institute
ASAHIKASEI KURAREY MEDICAL CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003727
