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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025936
Receipt No. R000029819
Scientific Title Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial
Date of disclosure of the study information 2017/02/20
Last modified on 2019/08/05

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Basic information
Public title Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial
Acronym J-ACNES
Scientific Title Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial
Scientific Title:Acronym J-ACNES
Region
Japan

Condition
Condition Cardiac sarcoidosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the evaluation of safety and efficacy between standard therapy (steroid only) and combination therapy (steroid + clarithromycin + doxycycline) for cardiac sarcoidosis patient
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the change of SUV level from baseline in FDG-PET/CT examination (6 months after study enroll)
Key secondary outcomes the frequency of steroid dose increasing (12 months after study enroll)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 combination therapy group:
Prednisolone; Predonisolone start from 30mg/day and continue same dose for one month. After one month, prednisolone decrease 25mg, 20mg, 15mg, 10mg every 2-4 weeks. Finally, maintenance dose of predonisolone is 7.5mg.
Antimicrobial agent; Clarithromycin start from 400mg/day for 24weeks. Doxycycline start 100mg/day for 22 weeks after 2 months of clarithromycin therapy.
Interventions/Control_2 Prednisolone; Predonisolone start from 30mg/day and continue same dose for one month. After one month, prednisolone decrease 25mg, 20mg, 15mg, 10mg every 2-4 weeks. Finally, maintenance dose of predonisolone is 7.5mg.
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

Not applicable
Gender Male and Female
Key inclusion criteria Cardiac sarcoidosis patient who have positive finding of FDG-PET and/or Ga scintigram and indication of steroid therapy.
Key exclusion criteria liver or kideny dysfunction, active infection, contraindication of drugs, corticosteroid therapy within 6 months for other disease, severe diabetes mellitus, and pregnancy
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kengo
Middle name
Last name Kusano
Organization National cerebral and cardiovascular center
Division name department of cardiovascular medicine
Zip code 5648565
Address 6-1 Kishibeshinmachi, Suita, Osaka, Japan
TEL 0661701070
Email kusanokengo@gmail.com

Public contact
Name of contact person
1st name Kengo
Middle name
Last name Kusano
Organization National cerebral and cardiovascular center
Division name department of cardiovascular medicine
Zip code 5648565
Address 6-1 Kishibeshinmachi, Suita, Osaka, Japan
TEL 0661701070
Homepage URL
Email kusanokengo@gmail.com

Sponsor
Institute National cerebral and cardiovascular center
Institute
Department

Funding Source
Organization National cerebral and cardiovascular center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National cerebral and cardiovascular center research ethics committee
Address 6-1 Kishibeshinmachi, Suita, Osaka, Japan
Tel 0661701070
Email plandiv@ml.ncvc.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 20 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 12 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
2017 Year 01 Month 31 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029819

Research Plan
Registered date File name
2018/08/08 J-ACNES試験_臨床試験実施計画書第2.5版2018年7月9日.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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