UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001943 |
|---|---|
| Receipt number | 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 17:50:13 |
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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
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
sho01011125@yahoo.co.jp
Sponsor or person
Institute
The Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002322
