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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

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 - Observational study of lupus nephritis using database

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051632
Enrollment
1135
Registered
2023-09-01
Start date
2023-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lupus nephritis

Interventions

None listed

Sponsors

Otsuka Pharmaceuticals Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
UPCR Proteinuria (semi-quantitative analysis, -to 4+)

Secondary

MeasureTime frame
Clinical events Biochemical tests Renal function tests Hematology tests Vital signs Comorbidities Inpatient/outpatient

Countries

Japan

Contacts

Public ContactShinichi Nishiwaki

Otsuka Pharmaceuticals Co., Ltd Medical Affairs Department

Nishiwaki.Shinichi@otsuka.jp06-6943-7722

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026