UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025936 |
|---|---|
| Receipt number | R000029819 |
| Scientific Title | Japanese AntibaCterial drug maNagemEnt for cardiac Sarcoidosis Trial |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2025/08/14 10:30:54 |
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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
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
kusanokengo@gmail.com
Sponsor or person
Institute
National cerebral and cardiovascular center
Institute
Department
Personal name
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
rec-office-ac@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
29
Results
No significant differences were found between the control group and the intervention group, so observation will continue in an observational study.
Results date posted
| 2023 | Year | 02 | Month | 09 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to delays in analysis
Date of the first journal publication of results
Baseline Characteristics
cardiac sarcoidosis
Participant flow
cardiac sarcoidosis
Adverse events
Adverse event　12events(included　7serious adverse events)
Outcome measures
Change from baseline in total SUV by FDG-PET/CT (at 6 months after administration)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
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
| 2025 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029819
