UMIN-CTR Clinical Trial

Public title

A prospective and multicenter trial of intravenous immunoglobulin therapy for idiopathic pulmonary fibrosis

Acronym

Intravenous immunoglobulin therapy for IPF

Scientific Title

A prospective and multicenter trial of intravenous immunoglobulin therapy for idiopathic pulmonary fibrosis

Scientific Title:Acronym

Intravenous immunoglobulin therapy for IPF

Region

Japan

Condition

Idiopathic pulmonary fibrosis

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine the efficacy and safety of intravenous immunoglobulin (IVIG) therapy for Idiopathic pulmonary fibrosis

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Change in vital capacity

Key secondary outcomes

Changes in diffusion capacity of the lung for carbon monoxide (DLCO), 6-minute walk test, and high-resolution computed tomography (HRCT) findings

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients were treated with intravenous immunoglobulin (IVIG) at 0.4 g/kg/day for 5 consecutive days (5-day IVIG group)

Interventions/Control_2

Patients were treated with intravenous immunoglobulin (IVIG) at 0.4 g/kg/day once-monthly for 5 consecutive months (5-month IVIG group)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients with adequate oxygenation as evidenced by: 1) an arterial oxygen pressure (PaO2) of 80 Torr or more at rest and minimum saturation of peripheral oxygen (SpO2) of less than 90% in the 6 minutes walk test (6MWT), 2) PaO2 at rest of 70 Torr or more to less than 80 Torr or 3) PaO2 at rest of 60 Torr or more to less than 70 Torr and minimum SpO2 of 90 % or more in the 6MWT.

Key exclusion criteria

Coexisting or clinical suspicion of sarcoidosis, hypersensitivity pneumonitis, connective tissue diseases, pneumoconiosis, drug-induced pneumonitis, infectious disease, pregnancy, coexisting chronic obstructive pulmonary disease (COPD), bronchial asthma, bronchiectasis, neoplasm, severe cardiovascular disease, cerebrovascular disease, chronic kidney disease, or thromboembolism. Patients who were unable to undergo physiologic tests, unable to understand the protocol or provide written informed consent, or who were administered with 20 mg/day or more of predonisolone, immunosuppressive agents, antifibrotic agents, or immunoglobulin during the preceding 3 months

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Shoji Kudo

Organization

Fukujuji Hospital, Japan Anti-Tuberculosis Association

Division name

Department of respiratory medicine

Zip code

Address

3-1-24 Kiyoseshi, Tokyo, Japan

TEL

042-491-4911

Email

kudous@fukujuji.org

Name of contact person

1st name
Middle name
Last name	Noriyuki Enomoto

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

Address

1-20-1 Handayama, Higashiku, Hamamatsu, Japan

TEL

053-435-2263

Homepage URL

Email

norieno@hama-med.ac.jp

Institute

Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

Teijin Pharma Limited (Tokyo, Japan)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

KAKETSUKEN (Kumamoto, Japan)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

浜松医科大学内科学第２講座（静岡県）、国立病院機構相模原病院アレルギー科（神奈川県）、日本医科大学付属病院呼吸器感染症腫瘍内科（東京）、神奈川循環器呼吸器病センター呼吸器内科（神奈川）
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan
Clinical Research Center for Allergy and Rheumatology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, Kanagawa, Japan
Internal Medicine, Department of Pulmonary Medicine/Infection and Oncology, Nippon Medical School, Tokyo, Japan
Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan

Date of disclosure of the study information

2014

Year

03

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2008

Year

08

Month

20

Day

Date of IRB

Anticipated trial start date

2008

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

03

Month

30

Day

Last modified on

2014

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015487