UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053093 |
|---|---|
| Receipt number | R000060587 |
| Scientific Title | A descriptive observational research for the treatment pattern in patients with Lupus Nephritis using Japanese claim database |
| Date of disclosure of the study information | 2023/12/14 |
| Last modified on | 2023/12/13 19:38:41 |
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Basic information
Public title
A descriptive observational research for the treatment pattern in patients with Lupus Nephritis using Japanese claim database
Acronym
Observational research in patients with lupus nephritis using claim database
Scientific Title
A descriptive observational research for the treatment pattern in patients with Lupus Nephritis using Japanese claim database
Scientific Title:Acronym
Observational research in patients with lupus nephritis using claim 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 the oral glucocorticoid (GC) dose changes in patients with lupus nephritis who are introduced the induction treatment
Basic objectives2
Others
Basic objectives -Others
Proportion of patients on oral GC 5 mg/day or less (prednisolone equivalent) after 540 days from the Index Date
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients on oral GC 5 mg/day or less (prednisolone equivalent) after 540 days from the Index Date
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
LN Patients treated with induction treatment and meet all of the following (1) to (8):
(1) Diagnosed with lupus nephritis (defined as 7100007 excluding suspected cases in a disease code) for at least 2 months between May 2016 and March 2023
(2) Prescription of oral GC or steroid pulse therapy at the dose of 20 mg/day or more with a disease code 7100007 (lupus nephritis) issued in the same month
(3) Observable for at least 90 days prior to Index Date
(4) Observable for at least 540 days after the Index Date
(5) No oral GC or steroid pulse therapy 20 mg/day or more for 90 days prior to the Index Date
(6) Urinalysis was performed and the month in which a disease code 7100007 excluding suspected cases was given at least 2 months within 360 days after the Index Date
(7) Anti-DNA antibody test was performed and the month in which a disease code 7100007 excluding suspected cases was given at least 2 months within 360 days after the Index Date
(8) Complement Blood test was performed and the month in which a disease code 7100007 excluding suspected cases was given at least 2 months within 360 days after the Index Date
Dose of oral GC and steroid pulse are converted equivalent to prednisolone.
The Index Date shall be the date of the first date meeting the following conditions.
Date of prescription of oral GC 20 mg/day or more or date of first prescription of steroid pulses in the same month in which a disease code 7100007 excluding suspected cases was given.
Key exclusion criteria
Not applicable
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Nishijima |
Organization
CHUGAI PHARMACEUTICAL CO.,LTD.
Division name
Medical Affairs Div.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku Tokyo
TEL
03-3281-6611
cma-clinicaltrial@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Urakawa |
Organization
CHUGAI PHARMACEUTICAL CO.,LTD.
Division name
Medical Affairs Div.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku Tokyo
TEL
03-3281-6611
Homepage URL
cma-clinicaltrial@chugai-pharm.co.jp
Sponsor or person
Institute
CHUGAI PHARMACEUTICAL CO.,LTD.
Nippon Shinyaku Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.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
| 2023 | Year | 12 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Organization for analysis]
INTAGE Healthcare Inc.
[Organization providing data]
JMDC Inc.
Management information
Registered date
| 2023 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060587
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
