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 2023/08/07 14:02:47

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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 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

Email

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

Analyzing

Results date posted

2023 Year 02 Month 09 Day

Results Delayed

Delay expected

Results Delay Reason

analyzing

Date of the first journal publication of results


Baseline Characteristics


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

No longer recruiting

Date of protocol fixation

2016 Year 12 Month 07 Day

Date of IRB

2016 Year 12 Month 12 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

2023 Year 08 Month 07 Day



Link to view the page

Value
https://center6.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