UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021532 |
|---|---|
| Receipt number | R000024826 |
| Scientific Title | Immunolohistological analysis of lupus nephritis and other nephritis |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2020/01/27 14:33:36 |
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Basic information
Public title
Immunolohistological analysis of lupus nephritis and other nephritis
Acronym
Immunolohistological analysis of lupus nephritis and other nephritis
Scientific Title
Immunolohistological analysis of lupus nephritis and other nephritis
Scientific Title:Acronym
Immunolohistological analysis of lupus nephritis and other nephritis
Region
| Japan |
Condition
Condition
Lupus nephritis
ANCA-associated vasculitis
Nephritis associated with rheumatic diseases
Classification by specialty
| Medicine in general | Nephrology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primal goal of the study is to identify factors associated with prognosis of lupus nephritis. In addition to conventional clinical pathological diagnosis,immunohistochemical analysis to evaluate quantity and function of macrophages (such as HO-1) will be performed, using the specimen stored in the pathology department. Analysis of parameters such as pathological status, treatment response, survival are retrospectively analyzed. Disease controls are ANCA-associated vasculitis, nephritis caused by hypertention, diabetes etc are also included in the study.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of factors associated with prognosis of lupus nephritis.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All of the lupus nephritis patients need to fulfill ACR or SLICC criteria. ANCA associated vasculitis patients need to have ANCA positivity and pathological evidence of vasculitis.
Key exclusion criteria
The patients who are not willing to participate in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Nakajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem cell and Immune Regulation
Zip code
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama
TEL
045-787-2630
hnakajim@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Kirino |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem cell and Immune Regulation
Zip code
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama
TEL
045-787-2630
Homepage URL
kirino@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
JAPANESE RHEUMATIC FOUNDATION
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 18 | 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
| 2014 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case control study.
Patients who visited our hospital after March 18, 2016, or the patients who had performed kidney biopsy before March 18, 2016. Pathological findings, treatments, renal condition are retrospectively analyzed.
Management information
Registered date
| 2016 | Year | 03 | Month | 18 | Day |
Last modified on
| 2020 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024826
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
