Unique ID issued by UMIN | UMIN000031999 |
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Receipt number | R000036523 |
Scientific Title | A multicenter, cooperative prospective, nonrandomized, open-label, comparative study using historical controls to verify the effectiveness of simple plasma exchange therapy for patients with the most severe form ANCA associated vasculitis |
Date of disclosure of the study information | 2018/04/01 |
Last modified on | 2023/04/04 09:39:10 |
A multicenter, cooperative prospective, nonrandomized, open-label, comparative study using historical controls to verify the effectiveness of simple plasma exchange therapy for patients with the most severe form ANCA associated vasculitis
Efficacy verification trial of plasma exchange therapy for the most severe form ANCA associated vasculitis
A multicenter, cooperative prospective, nonrandomized, open-label, comparative study using historical controls to verify the effectiveness of simple plasma exchange therapy for patients with the most severe form ANCA associated vasculitis
Efficacy verification trial of plasma exchange therapy for the most severe form ANCA associated vasculitis
Japan |
ANCA associated vasculitis
Clinical immunology |
Others
NO
Verify the effectiveness of plasma exchange therapy for the most severe type ANCA-associated vasculitis
Efficacy
One year survival rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Medicine | Device,equipment |
Plasma exchange
Plasma exchange therapy should be performed once with 2.0 to 3.0 L and three times as one course. Nafamostat mesilate is used as an anticoagulant and fresh frozen plasma is used as a replenisher. Until the introduction of remission, the number of enforcement courses will be decided appropriately between 1 and 6 courses depending on the condition. For this reason, the total number of plasma exchange therapies ranges from 3 to a maximum of 18, resulting in a fresh frozen plasma transfusion volume of 6.0 L to 54.0 L.
20 | years-old | <= |
Not applicable |
Male and Female
Fulfill classification criteria for ANCA-associated vasculitis of any age 20 years or older, written in written form, either microscopic polyangiitis, polyangiitis granulomatosis, eosinophilic polyangiitis granulomatosis Patients who have newly developed or relapsed the condition that becomes the most severe type this time.
If there is a withdrawal of consent of research cooperation from the research subject.
When the whole research is canceled.
If for other reasons the researcher judges that the cancellation of research is appropriate.
When adverse reactions with difficult plasma continuation therapy appear.
6
1st name | Naoto |
Middle name | |
Last name | Tamura |
Juntendo university
Department of Internal Medicine and Rheumatology
1130033
2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
0338133111
tnaoto@juntendo.ac.jp
1st name | Yoshiyuki |
Middle name | |
Last name | Abe |
Juntendo university
Department of Internal Medicine and Rheumatology
1130033
2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
0338133111
yo-abe@juntendo.ac.jp
Juntendo university
None
Other
Juntendo University
2-1-1, Hongo, Bunkyo-Ku, Tokyo
0338133111
kenkyu5858@juntendo.ac.jp
NO
順天堂大学医学部附属順天堂醫院
順天堂東京江東高齢者医療センター
2018 | Year | 04 | Month | 01 | Day |
https://onlinelibrary.wiley.com/doi/10.1111/1744-9987.13824
Published
https://onlinelibrary.wiley.com/doi/10.1111/1744-9987.13824
4
The 52-week survival rate of patients in the PE group (n = 4) was higher than that of the historical control group (n = 16) (100% vs. 13%, p = 0.04).
2023 | Year | 04 | Month | 04 | Day |
The median age was 79 years, and three of the four patients were women.
Diffuse alveolar hemorrhage was the initial symptom in 3 patients and was the symptom at relapse in 1 patient.
The median BVAS was 19 points.
Written consent was obtained for patients with severe ANCA-associated vasculitis with diffuse alveolar hemorrhage.
This was a one-arm study with a historical control group, and all consenters were informed that they would receive plasma exchange therapy.
Nothing of note.
Primary outcome measure
The primary outcome measure was the 52-week survival rate among patients in each treatment arm.
Secondary outcome measure
There were no secondary outcome measures in this study. The details and results of daily clinical practice were analyzed.
Completed
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 03 | Month | 23 | Day |
2018 | Year | 04 | Month | 01 | Day |
2022 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 30 | Day |
2023 | Year | 04 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036523
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