UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051632 |
|---|---|
| Receipt number | R000058917 |
| Scientific Title | A descRiptive obsErvational research for the preValence, trEAtment pattern, and Long-term risk of Lupus Nephritis in real world clinical practice using Japanese EMR/Claim database |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2025/11/26 09:57:37 |
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Basic information
Public title
A descRiptive obsErvational research for the preValence, trEAtment pattern, and Long-term risk of Lupus Nephritis in real world clinical practice using Japanese EMR/Claim database
Acronym
Observational study of lupus nephritis using database
Scientific Title
A descRiptive obsErvational research for the preValence, trEAtment pattern, and Long-term risk of Lupus Nephritis in real world clinical practice using Japanese EMR/Claim database
Scientific Title:Acronym
Observational study of lupus nephritis using database
Region
| Japan |
Condition
Condition
lupus nephritis
Classification by specialty
| Nephrology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe clinical events involve the morbidity, clinical characteristics, complications, treatment status, renal prognosis including UPCR/eGFR, and clinical events including end-stage renal failure/renal replacement therapy/all-cause and renal mortality in lupus nephritis patients in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
UPCR
Proteinuria (semi-quantitative analysis, -to 4+)
Key secondary outcomes
Clinical events
Biochemical tests
Renal function tests
Hematology tests
Vital signs
Comorbidities
Inpatient/outpatient
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
LN patients are indicated as diagnosed with SLE and following under either (1) or (2), and also following under (3).
(1) Individuals diagnosed with LN at the time of SLE diagnosis or after diagnosis
(2) Individuals with SLE and any of the following criteria, who should be LN individuals.
Individuals who have been seen at least once in the nephrology department at the time of SLE diagnosis or after diagnosis
Patients with >1 diagnosis (non-diagnostic medical claim) for acute or chronic renal conditions, including glomerulonephritis (including lupus glomerulonephritis), acute or chronic renal failure, nephritis, ore nephrotic syndrome (including lupus nephrotic syndrome), renal failure, ore proteinuria at the time of SLE diagnosis or after diagnosis.
Evidence of ESRD at the time of SLE diagnosis or after diagnosis
Evidence use of cyclophosphamide, cyclosporine, rituximab, or tacrolimus at or after SLE diagnosis.
(3)Individuals aged 18 years or older at LN examination
Key exclusion criteria
Individuals with a diagnosis of LN in the previous from 3 months to 6 months after the first time of LN diagnosis during the inclusion period
Target sample size
1135
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27 Ote-dori,Chuo-ku,Osaka
TEL
06-6943-7722
Nishiwaki.Shinichi@otsuka.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27 Ote-dori,Chuo-ku,Osaka
TEL
06-6943-7722
Homepage URL
Nishiwaki.Shinichi@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceuticals Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceuticals Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address
463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel
088-665-2126
Suzuki.Takashi@otsuka.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
| 2023 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
2768
Results
Data regarding temporal variations in the urine protein-to-creatinine ratio (UPCR), corticosteroid utilization, and associated clinical events were presented, thereby providing a potential foundation for the development of therapeutic strategies in patients with active lupus nephritis.
Results date posted
| 2025 | Year | 11 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among the 2,768 patients with active lupus nephritis (LN) analyzed, 66.4% were female, and the mean(SD) age at diagnosis of LN was 59.4(19.3) years.
Participant flow
The study included patients who satisfied the predefined inclusion and exclusion criteria, based on data make by Real World Data Inc. (currently JMDC Corporation) from January 1, 1985, to December 31, 2022, encompassing electronic medical records, Diagnosis Procedure Combination (DPC) data, and insurance claims data.
Adverse events
NA
Outcome measures
Following the diagnosis of lupus nephritis, seventy-four point nine percent of patients achieved remission of proteinuria, and among those who achieved remission, forty-nine point six percent experienced a relapse of proteinuria thereafter. Furthermore, fifty-six point zero percent of patients reached complete renal remission after diagnosis. The median survival times for achieving remission of proteinuria, relapse of proteinuria, and complete renal remission were eighty-nine days (ninety-five percent confidence interval: eighty-four to ninety-eight days), nine hundred ten days (eight hundred twelve to one thousand fifty-seven days), and three hundred thirty-four days (two hundred seventy to three hundred ninety-two days), respectively. Among clinical events observed after diagnosis, the highest incidence was diabetes mellitus (thirty-eight point seven percent), followed by osteoporosis (twenty-nine point six percent) and renal failure (twenty-five point six percent).
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To describe the morbidity of LN in SLE patients, patient background information, and clinical characteristics. In addition, to investigate the actual treatment status, the duration of drug trial, the timing of drug discontinuation, and their relationship to treatment outcome in patients with LN.
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058917
