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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001943
Receipt No. R000002322
Scientific Title A retrospective analysis of the association between histological lesion and renal outcome in patients with lupus nephritis
Date of disclosure of the study information 2009/05/18
Last modified on 2009/04/27

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Basic information
Public title A retrospective analysis of the association between histological lesion and renal outcome in patients with lupus nephritis
Acronym A retrospective analysis of the association between histological lesion and renal outcome in patients with lupus nephritis
Scientific Title A retrospective analysis of the association between histological lesion and renal outcome in patients with lupus nephritis
Scientific Title:Acronym A retrospective analysis of the association between histological lesion and renal outcome in patients with lupus nephritis
Region
Japan

Condition
Condition lupus nephritis
Classification by specialty
Medicine in general Nephrology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In 2003, the ISN/RPS classification was proposed. Although this new classification has achieved one of its aims in improving interobserver reproducibility by clarification of definition, the association between each histological lesion and renal outcome has not been evaluated.
We evaluated the association between the new classification and renal outcome retrospectively. We also attempted to define a novel prognostic score based on the histological predictors of renal outcome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the histological predictors of renal prognosis
Key secondary outcomes the association between the new classification and renal outcome

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 biopsy-proven LN in our hospital from 1990 to 2006
Key exclusion criteria the cases of death
Target sample size 99

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makino Hirofumi
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name The Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-cho, Okayama City, Okayama, 700-8558, Japan
TEL 086-235-7235
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kojo Shoichiro
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name The Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-cho, Okayama City, Okayama, 700-8558, Japan
TEL 086-235-7786
Homepage URL
Email sho01011125@yahoo.co.jp

Sponsor
Institute The Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2009 Year 05 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www2.convention.co.jp/jsn51/
Number of participants that the trial has enrolled
Results
The 51nd Annual Scientific Meeting of the Japanese Society of Nephrology(2008.5.30-6.1)

  In class IV, the IV-G group tended to exhibit a worse renal outcome compared with the IV-S group, but the difference was not significant (log-rank test, P = 0.4330).  Independent histological predictors of poor renal outcome were extracapillary proliferation, glomerular sclerosis and fibrous crescents analyzed by Cox proportional hazards model, while predictors of favorable renal outcome were hyaline thrombi and fibrous adhesions.  By the prognostic score, renal outcome was significantly worse in the group with the higher score (> or = 0.25) than in the group with the lower score (< 0.25) in class IV patients (log-rank test, P < 0.001).
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
2007 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2007 Year 07 Month 01 Day
Date of closure to data entry
2007 Year 09 Month 01 Day
Date trial data considered complete
2007 Year 09 Month 01 Day
Date analysis concluded
2008 Year 01 Month 01 Day

Other
Other related information retrospective study

Management information
Registered date
2009 Year 05 Month 06 Day
Last modified on
2009 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002322

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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