UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039985 |
|---|---|
| Receipt number | R000045590 |
| Scientific Title | Disease control of patients with newly screening-detected hyperuricemia: A retrospective cohort study of health insurance claims and medical check-up data |
| Date of disclosure of the study information | 2020/03/30 |
| Last modified on | 2021/10/18 13:20:31 |
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Basic information
Public title
Disease control of patients with newly screening-detected hyperuricemia: A retrospective cohort study of health insurance claims and medical check-up data
Acronym
Disease control of patients with newly screening-detected hyperuricemia
Scientific Title
Disease control of patients with newly screening-detected hyperuricemia: A retrospective cohort study of health insurance claims and medical check-up data
Scientific Title:Acronym
Disease control of patients with newly screening-detected hyperuricemia
Region
| Japan |
Condition
Condition
Gout, hyperuricemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between the disease control status and onset of gouty arthritis in patients with newly screening-detected asymptomatic hyperuricemia
Basic objectives2
Others
Basic objectives -Others
Real clinical practice
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Disease control status (Association between prescription of urate-lowering therapy, onset of gouty arthritis, and serum uric acid level after 1-year)
2. Disease burden for disease control status (frequency of gouty arthritis)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who have a serum uric acid level of 8.0 mg/dL or more at least one during the medical check-ups between April 2013 and March 2016
2. Subjects for whom eGFR data are available on the same day when the serum uric acid level of 8.0 mg/dL or more for the first time (index date)
3. Subjects for whom serum uric acid level are available within 1 year after the index date (follow up date)
4. Subjects over the age of 18 on the index date
5. Subjects who have consecutively registered in the health insurance claims database for at least 12 months before the index month and for 24 months after the follow up date
Key exclusion criteria
1. Patients who identified gout or asymptomatic hyperuricemia during the index period
2. Patients who received prescriptions of urate-lowering therapy during the index period
3. Patients who identified malignant neoplasms during the index period
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Horiuchi |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
tpm-com@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ruriko |
| Middle name | |
| Last name | Koto |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
Homepage URL
tpm-com@umin.ac.jp
Sponsor or person
Institute
Teijin Pharma Limited
Institute
Department
Personal name
Funding Source
Organization
None
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
Teijin Pharma Limited
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
Tel
03-3506-4140
tpm-com@umin.ac.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
| 2020 | Year | 03 | Month | 30 | 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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective cohort study using the JMDC Claims Database.
Management information
Registered date
| 2020 | Year | 03 | Month | 30 | Day |
Last modified on
| 2021 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045590
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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