UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015187 |
|---|---|
| Receipt number | R000017107 |
| Scientific Title | Observational Cohort Study of Remission Maintenance Therapy in Japanese Patients with ANCA-associated Vasculitis and rapidly progressive glomerulonephritis |
| Date of disclosure of the study information | 2014/09/17 |
| Last modified on | 2020/03/23 10:56:08 |
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Basic information
Public title
Observational Cohort Study of Remission Maintenance Therapy in
Japanese Patients with ANCA-associated Vasculitis and rapidly progressive glomerulonephritis
Acronym
Co-RemIT-JAV-RPGN
Scientific Title
Observational Cohort Study of Remission Maintenance Therapy in
Japanese Patients with ANCA-associated Vasculitis and rapidly progressive glomerulonephritis
Scientific Title:Acronym
Co-RemIT-JAV-RPGN
Region
| Japan |
Condition
Condition
ANCA-associated vasculitis
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Nephrology | Clinical immunology | Dermatology |
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and efficacy of remission maintenance therapy in Japanese patients with ANCA-associated vasculitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse
Key secondary outcomes
Renal survival
Survival
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ANCA-associated vasculitis registered in RemIT-JAV-RPGN study and under the remission maintenancy therapy
Key exclusion criteria
Patients without the agreement
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Arimura |
Organization
Kyorin University School of Medicine
Division name
First Department of Internal Medicine
Zip code
1818611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
vas-mhlw@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken-ei |
| Middle name | |
| Last name | Sada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
1818611
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7235
Homepage URL
sadakenn@md.okayama-u.ac.jp
Sponsor or person
Institute
the Research Committee on Intractable Vasculitides, the Ministry of Health, Labour and Welfare of Japan
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2, Shinkawa, Mitaka, Tokyo 181-8611, Japan
Tel
0422-47-5514
rec@ks.kyorin-u.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
| 2014 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&language
Publication of results
Unpublished
Result
URL related to results and publications
http://mhlw-grants.niph.go.jp/niph/search/NIDD00.do?resrchNum=201610012A
Number of participants that the trial has enrolled
123
Results
Under data cleaning
Results date posted
| 2019 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Under data cleaning
Participant flow
Under data cleaning
Adverse events
Under data cleaning
Outcome measures
Under data cleaning
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Medical data on each patient are collected to clarify the safety and efficacy of remission maintenance therapy in Japanese patients with ANCA-associated vasculitis.
Management information
Registered date
| 2014 | Year | 09 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017107
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
