UMIN-CTR Clinical Trial

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
Email	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
Email	kirino@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024826