UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042946
Receipt number R000048981
Scientific Title Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)
Date of disclosure of the study information 2021/02/01
Last modified on 2024/01/11 12:01:07

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Basic information

Public title

Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)

Acronym

Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)

Scientific Title

Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)

Scientific Title:Acronym

Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)

Region

Japan


Condition

Condition

Idiopathic pleuroparenchymal fibroelastosis

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of nintedanib in patients with idiopathic pleuroparenchymal fibroelastosis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

%FVC decline rate during 26-week treatment of nintedanib versus the rate of baseline

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

150 mg bid nintedanib over 26 weeks

Interventions/Control_2


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

Provided written informed consent
Confirmed definite idiopathic PPFE or probable idiopathic PPFE before the registration
Have more than 50% of %FVC
Have more than relative 5% decline of %FVC within 1 year of visit 1
etc.

Key exclusion criteria

Have a history of treatment either with pirfenidone or nintedanib
NAC, prednisone > 15 mg/day or equivalent, azathioprine, cyclosporine or cyclophosphamide received within 8 weeks of visit 1
Have airway obstruction
Have lung cancer
Have pulmonary hypertension
Developed acute exacerbation within 3 months of visit 1
etc.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yasuhiko
Middle name
Last name Nishioka

Organization

Graduate School of Biomedical Sciences
Tokushima University

Division name

Department of Respiratory Medicine and Rheumatology

Zip code

770-8503

Address

3-18-15, Kuramoto-cho, Tokushima, Japan

TEL

088-633-7127

Email

yasuhiko@tokushima-u.ac.jp


Public contact

Name of contact person

1st name Kojin
Middle name
Last name Murakami

Organization

Graduate School of Biomedical Sciences Tokushima University

Division name

Department of Respiratory Medicine and Rheumatology

Zip code

770-8503

Address

3-18-15, Kuramoto-cho, Tokushima, Japan

TEL

088-633-7127

Homepage URL


Email

murakami.kojin@tokushima-u.ac.jp


Sponsor or person

Institute

Department of Respiratory Medicine and Rheumatology
Graduate School of Biomedical Sciences
Tokushima University

Institute

Department

Personal name



Funding Source

Organization

None

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

Tokushima University Hospital

Address

2-50-1, Kuramoto-cho, Tokushima, Japan

Tel

088-633-9294

Email

awachiken@tokushima-u.ac.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

2021 Year 02 Month 01 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

2021 Year 02 Month 01 Day

Date of IRB

2021 Year 01 Month 25 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2025 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The trial is on going. 11/Jan/2024


Management information

Registered date

2021 Year 01 Month 08 Day

Last modified on

2024 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048981


Research Plan
Registered date File name
2022/01/09 1)研究計画書 第2.1版.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name