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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013559
Receipt No. R000015487
Scientific Title A prospective and multicenter trial of intravenous immunoglobulin therapy for idiopathic pulmonary fibrosis
Date of disclosure of the study information 2014/03/30
Last modified on 2014/03/30

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Basic information
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
Condition Idiopathic pulmonary fibrosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization Teijin Pharma Limited (Tokyo, Japan)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) KAKETSUKEN (Kumamoto, Japan)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 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

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 30 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 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
Other related information

Management information
Registered date
2014 Year 03 Month 30 Day
Last modified on
2014 Year 03 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015487

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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