A study on the actual state of IgA nephropathy patients from urinalysis abnormalities in health checkups to diagnosis and treatment using health checkup data and health insurance claims data in Japan

A descriptive study on the actual state of IgA nephropathy patients from urinalysis abnormalities in health checkups to diagnosis and treatment using health checkup data and health insurance claims data from the health insurance claims database in Japan - A descriptive study on the actual state of IgA nephropathy patients from urinalysis abnormalities in health checkups to diagnosis and treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058225

Enrollment

4500

Registered

2025-07-01

Start date

2025-07-01

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

IgA nephropathy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The patient is registered in the subscriber register of the health insurance claims data provided by JMDC Inc. during the inclusion period. 2. The patient has been diagnosed with IgA nephropathy (ICD-10 code: N028) during the inclusion period. 3. The patient has undergone a renal biopsy (including procedures that are thought to be renal biopsies) during the inclusion period. 4. Among the above renal biopsies, there is at least one case where the diagnosis of IgA nephropathy (ICD-10 code: N028) was made within one year of the procedure. 5. At the time of the index date, the patient is aged 18 years or over but under 75 years of age.

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
The period from the earliest abnormal hematuria or proteinuria, or both, to diagnosis (renal biopsy)	—

Secondary

Measure	Time frame
1. The period from the onset of abnormal hematuria to diagnosis (renal biopsy) and the period from the onset of abnormal proteinuria to diagnosis (renal biopsy) 2. The number and proportion of patients by category: those with abnormal hematuria prior to proteinuria, simultaneous abnormal hematuria and proteinuria, abnormal proteinuria prior to hematuria, and no abnormalities until the end of evaluation 3. The period from the onset of both abnormal hematuria and proteinuria to diagnosis (renal biopsy) 4. The number and proportion of patients who underwent urine tests at medical institutions after the earliest abnormal hematuria or proteinuria (by hospital bed count), the period from the earliest abnormal hematuria or proteinuria to the first urine test, and the period from the test to the renal biopsy 5. The number and proportion of patients who underwent quantitative tests for proteinuria between the urinalysis abnormalities in health checkups and the renal biopsy, and hospital bed distribution at medical institutions that performed quantitative tests for proteinuria 6. The period from the earliest abnormal hematuria or proteinuria to the first quantitative test for proteinuria, and from the test to the renal biopsy 7. The number and proportion of patients who underwent urine sediment tests between the urinalysis abnormalities in health checkups and the renal biopsy, and hospital bed distribution at medical institutions that performed urine sediment tests 8. The period from the earliest abnormal hematuria or proteinuria to the first urine sediment test, and from the test to the renal biopsy 9. Focusing on initial treatment, the period from diagnosis (renal biopsy) to the initiation of the first IgA nephropathy-related treatment and the period from diagnosis (renal biopsy) to the initiation of each IgA nephropathy-related treatment 10. The initial treatment content based on the most recent health checkup results before diagnosis (renal biopsy)	—

Measure

Time frame

1. The period from the onset of abnormal hematuria to diagnosis (renal biopsy) and the period from the onset of abnormal proteinuria to diagnosis (renal biopsy) 2. The number and proportion of patients by category: those with abnormal hematuria prior to proteinuria, simultaneous abnormal hematuria and proteinuria, abnormal proteinuria prior to hematuria, and no abnormalities until the end of evaluation 3. The period from the onset of both abnormal hematuria and proteinuria to diagnosis (renal biopsy) 4. The number and proportion of patients who underwent urine tests at medical institutions after the earliest abnormal hematuria or proteinuria (by hospital bed count), the period from the earliest abnormal hematuria or proteinuria to the first urine test, and the period from the test to the renal biopsy 5. The number and proportion of patients who underwent quantitative tests for proteinuria between the urinalysis abnormalities in health checkups and the renal biopsy, and hospital bed distribution at medical institutions that performed quantitative tests for proteinuria 6. The period from the earliest abnormal hematuria or proteinuria to the first quantitative test for proteinuria, and from the test to the renal biopsy 7. The number and proportion of patients who underwent urine sediment tests between the urinalysis abnormalities in health checkups and the renal biopsy, and hospital bed distribution at medical institutions that performed urine sediment tests 8. The period from the earliest abnormal hematuria or proteinuria to the first urine sediment test, and from the test to the renal biopsy 9. Focusing on initial treatment, the period from diagnosis (renal biopsy) to the initiation of the first IgA nephropathy-related treatment and the period from diagnosis (renal biopsy) to the initiation of each IgA nephropathy-related treatment 10. The initial treatment content based on the most recent health checkup results before diagnosis (renal biopsy)

—

Countries

Japan

Contacts

Public ContactRikiya Toda

Otsuka Pharmaceutical Co., Ltd. Medical Affairs

Toda.Rikiya.a@otsuka.jp03-6717-1400

Outcome results