UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036873 |
|---|---|
| Receipt number | R000042015 |
| Scientific Title | Analysis of clinical features and prognosis of anti-neutrophil cytoplasmic antibody-associated vasculitis |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2021/11/30 23:42:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of clinical features and prognosis of anti-neutrophil cytoplasmic antibody-associated vasculitis
Acronym
Analysis of clinical features and prognosis of anti-neutrophil cytoplasmic antibody-associated vasculitis
Scientific Title
Analysis of clinical features and prognosis of anti-neutrophil cytoplasmic antibody-associated vasculitis
Scientific Title:Acronym
Analysis of clinical features and prognosis of anti-neutrophil cytoplasmic antibody-associated vasculitis
Region
| Japan |
Condition
Condition
anti-neutrophil cytoplasmic antibody associated vasculitis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
analysis of clinical features and prognosis
Basic objectives2
Others
Basic objectives -Others
To study organ involvement associated with vasculitis, outcomes of relapses, occurrences of adverse events, discontinuing of immunosuppressants, and survival rate.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To study outcomes of relapses, occurrences of adverse events, discontinuing of immunosuppressants, and survival rate, for five years.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with vasculitis, whose ANCA is positive, attending Clinical Immunology and Rheumatology, Jichi Medical University Hospital.
Key exclusion criteria
none
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Murosaki |
Organization
Jichi Medical University Hospital
Division name
Clinical Immunology and Rheumatology
Zip code
3290498
Address
3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture
TEL
0285587358
r0752tm@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Murosaki |
Organization
Jichi Medical University Hospital
Division name
Clinical Immunology and Rheumatology
Zip code
3290498
Address
3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture
TEL
0285587358
Homepage URL
r0752tm@jichi.ac.jp
Sponsor or person
Institute
Jichimedical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JIchi Medical University
Address
3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture
Tel
0285588933
rinri@jichi.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
| 2019 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32996696/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32996696/
Number of participants that the trial has enrolled
162
Results
The multivariable Cox proportional hazards regression analysis showed that age over than 65: HR 1.69, 95 percent CI 1.07 to 2.81, p equal 0.025, performance status of 3 to 4: HR 1.98, 95 percent CI 1.21 to 3.23, p equal 0.008, cumulative dose of prednisolone over than 1,500mg : HR 2.21, 95 percent CI 1.37 to 3.81, p lower than 0.001, and oral cyclophosphamide: HR 1.84, 95 percent CI 1.13 to 3.00, p equal 0.016 were independent risk factors for immunosuppressant discontinuation.
Results date posted
| 2021 | Year | 11 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
162 patients who diagnosed with ANCA associate vasculitis from 2005 to 2016 in our institution
Participant flow
50 patients who were treated with immunosuppressant for initial remission induction
Adverse events
none (this is retrospective study)
Outcome measures
Discontinuation of immunosuppressant due to adverse event was evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 09 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 09 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 09 | Day |
Other
Other related information
We analyze the clinical informations including clinical features, for example relapse, organ involvement, adverse event, discontinuing of immunosuppressant, and survival rate, retrospectively, about patients with ANCA associated vasculitis attending our devision.
Management information
Registered date
| 2019 | Year | 05 | Month | 28 | Day |
Last modified on
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042015
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
