UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024090 |
|---|---|
| Receipt number | R000027734 |
| Scientific Title | An observational study of outcomes in adult lupus nephritis patients : a nationwide retrospective cohort study. |
| Date of disclosure of the study information | 2016/09/16 |
| Last modified on | 2024/03/23 10:42:47 |
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Basic information
Public title
An observational study of outcomes in adult lupus nephritis patients : a nationwide retrospective cohort study.
Acronym
Study of outcomes of lupus nephritis
Scientific Title
An observational study of outcomes in adult lupus nephritis patients : a nationwide retrospective cohort study.
Scientific Title:Acronym
Study of outcomes of lupus nephritis
Region
| Japan |
Condition
Condition
Lupus nephritis
Classification by specialty
| Medicine in general | Nephrology | Clinical immunology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is a retrospective cohort study in adult patients who were registered in Japan Renal Biopsy Registry between Jan 2007 and Dec 2012, with a histological diagnosis of lupus nephritis. The primary goal of this study is to clarify renal outcomes of lupus nephritis in total and in each histological classes. The secondary goal is to examine patterns of initial treatment, rate of complete remission, mortality and complications in each histology. In addition, risk factors for deterioration of renal function and patient death are investigated.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Doubling of serum creatinine or end-stage renal disease requiring renal replacement therapy
Key secondary outcomes
1) A 50% increase in serum creatinine
2) End-stage renal disease requiring renal replacement therapy
3) Good renal outcome (serum creatinine =< 1.0mg/dl, at the final observation)
4) Death
5) Cardiovascular diseases
6) Malignant tumor
7) Complete remission at 6 months after initiation of treatment (or renal biopsy)
8) Complete remission at 12 months after initiation of treatment (or renal biopsy)
9) Repeat biopsy
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Already registered in J-RBR before Sep 17, 2013
2)Received renal biopsy between Jan 1, 2007 and Dec 31, 2012
3)18 years old or older at the time of biopsy
4)Fulfilled 4 or more of the ACR criteria for the classification of SLE
5)Registered with a histological diagnosis of lupus nephritis
6)Japanese
Key exclusion criteria
1)No medical records at 6 months or later after renal biopsy. Patients who reached a 50% increase in serum creatinine, end stage renal failure requiring renal replacement therapy or died were not excluded.
2)Insufficient biopsy sample for the diagnosis of ISN/RPS classification
3)Patients who are judged to be inappropriate for the study by the investigator.
4)Patients who decline participation of the study.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Keiju |
| Middle name | |
| Last name | Hiromura |
Organization
Gunma University Hospital
Division name
Division of Nephrology and Rheumatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8166
hiromura@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Ikeuchi |
Organization
Gunma University Hospital
Division name
Division of Nephrology and Rheumatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8166
Homepage URL
hikeuchi@gunma-u.ac.jp
Sponsor or person
Institute
Japanese Society of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Nephrology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Research, Gunma University Hospital
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8166
hikeuchi@gunma-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
| 2016 | Year | 09 | Month | 16 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2016 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | 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=R000027734
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/09/27 | 【資料1】ループス腎炎 研究計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
