UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058225 |
|---|---|
| Receipt number | R000066433 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/12/19 09:06:20 |
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Basic information
Public title
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
Acronym
A study on the actual state of IgA nephropathy patients from urinalysis abnormalities in health checkups to diagnosis and treatment
Scientific Title
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
Scientific Title:Acronym
A descriptive study on the actual state of IgA nephropathy patients from urinalysis abnormalities in health checkups to diagnosis and treatment
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the period and process from the urinalysis abnormalities in health checkups before diagnosis to diagnosis and the actual treatment state before and after diagnosis in IgA nephropathy patients.
Basic objectives2
Others
Basic objectives -Others
To clarify the period from the urinalysis abnormalities in health checkups before diagnosis to diagnosis in IgA nephropathy patients.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The period from the earliest abnormal hematuria or proteinuria, or both, to diagnosis (renal biopsy)
Key secondary outcomes
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)
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
| 75 | years-old | > |
Gender
Male and Female
Key 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.
Key exclusion criteria
NA
Target sample size
4500
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Kurihara |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Kurihara.Hitomi@otsuka.jp
Public contact
Name of contact person
| 1st name | Rikiya |
| Middle name | |
| Last name | Toda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
Toda.Rikiya.a@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
Ethics Review Committee, Kitamachi Clinic, Fujikeikai Medical Corporation
Address
1-1-3, KichijojiKitamachi, Musashino-si. Tokyo
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2025 | Year | 07 | Month | 01 | 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
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. Among these individuals, forty-nine point six percent subsequently experienced a relapse of proteinuria. Furthermore, fifty-six point zero percent attained complete renal remission after the initial diagnosis of lupus nephritis.The median survival time to proteinuria remission, proteinuria relapse, and complete renal remission was 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.The most frequent clinical event observed after the diagnosis of lupus nephritis was diabetes mellitus, occurring in thirty-eight point seven percent of patients, followed by osteoporosis at twenty-nine point six percent and renal failure at twenty-five point six percent.
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the period and process from the urinalysis abnormalities in health checkups before diagnosis to diagnosis and the actual treatment state before and after diagnosis in IgA nephropathy patients.
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066433
