Unique ID issued by UMIN | UMIN000013559 |
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Receipt number | 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 07:23:48 |
A prospective and multicenter trial of intravenous immunoglobulin therapy for idiopathic pulmonary fibrosis
Intravenous immunoglobulin therapy for IPF
A prospective and multicenter trial of intravenous immunoglobulin therapy for idiopathic pulmonary fibrosis
Intravenous immunoglobulin therapy for IPF
Japan |
Idiopathic pulmonary fibrosis
Pneumology |
Others
NO
To determine the efficacy and safety of intravenous immunoglobulin (IVIG) therapy for Idiopathic pulmonary fibrosis
Efficacy
Exploratory
Not applicable
Change in vital capacity
Changes in diffusion capacity of the lung for carbon monoxide (DLCO), 6-minute walk test, and high-resolution computed tomography (HRCT) findings
Interventional
Parallel
Non-randomized
Open -no one is blinded
Dose comparison
2
Treatment
Medicine |
Patients were treated with intravenous immunoglobulin (IVIG) at 0.4 g/kg/day for 5 consecutive days (5-day IVIG group)
Patients were treated with intravenous immunoglobulin (IVIG) at 0.4 g/kg/day once-monthly for 5 consecutive months (5-month IVIG group)
50 | years-old | <= |
75 | years-old | > |
Male and Female
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.
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
10
1st name | |
Middle name | |
Last name | Shoji Kudo |
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Department of respiratory medicine
3-1-24 Kiyoseshi, Tokyo, Japan
042-491-4911
kudous@fukujuji.org
1st name | |
Middle name | |
Last name | Noriyuki Enomoto |
Hamamatsu University School of Medicine
Second Division, Department of Internal Medicine
1-20-1 Handayama, Higashiku, Hamamatsu, Japan
053-435-2263
norieno@hama-med.ac.jp
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Teijin Pharma Limited (Tokyo, Japan)
Profit organization
Japan
KAKETSUKEN (Kumamoto, Japan)
NO
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
2014 | Year | 03 | Month | 30 | Day |
Unpublished
Completed
2008 | Year | 08 | Month | 20 | Day |
2008 | Year | 10 | Month | 01 | Day |
2014 | Year | 03 | Month | 30 | Day |
2014 | Year | 03 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015487
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