UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057910 |
|---|---|
| Receipt number | R000066196 |
| Scientific Title | Study on the clinical benefits of achieving serum uric acid levels below 6.0 mg/dL: A Database Approach |
| Date of disclosure of the study information | 2025/05/19 |
| Last modified on | 2025/05/19 18:21:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on the clinical benefits of achieving serum uric acid levels below 6.0 mg/dL: A Database Approach
Acronym
Study on the clinical benefits of achieving serum uric acid levels below 6.0 mg/dL: A Database Approach
Scientific Title
Study on the clinical benefits of achieving serum uric acid levels below 6.0 mg/dL: A Database Approach
Scientific Title:Acronym
Study on the clinical benefits of achieving serum uric acid levels below 6.0 mg/dL: A Database Approach
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 how renal function and the incidence rates of events change when serum uric acid levels are lowered to below 6.0 mg/dL with uric acid-lowering agents, compared to the absence of uric acid-lowering agents, using a health insurance claims database.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. eGFR Slope
2. Changes in clinical laboratory data
3. Incidence rates of events
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. Database registration within the database period.
2. Subjects whose serum uric acid levels are available at least once during the observation period and whose uric acid values are 8.0 mg/dL or higher at any point. The date when the serum uric acid level first exceeds 8.0 mg/dL is defined as the index date.
3. Participants whose eGFR values are available on the index date and at 365 days, plus or minus 180 days following the index date.
4. Subjects whose serum uric acid levels have been recorded on the same day as 365 days, plus or minus 180 days after the index date, as specified in inclusion criteria 3. The date closest to 365 days after the index date is defined as the follow-up date. If multiple dates are applicable, the most recent one will be chosen as the follow-up date.
5. Subjects over the age of 18 on the index date.
6. 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. Subjects who were prescribed uric acid-lowering agents from the month before the index date to the month that is 12 months prior to the index date.
2. Subjects who have been diagnosed with gout or hyperuricemia from the month before the index date to the month that is 12 months prior to the index date.
3. Subjects who have been diagnosed with cancer from the month before the index date to the month that is 12 months prior to the index date.
4. Subjects whose serum uric acid values are 50 mg/dL or higher on the index date.
Target sample size
107600
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Kinjo |
Organization
MOCHIDA PHARMACEUTICAL CO., LTD.
Division name
MEDICAL AFFAIRS
Zip code
160-8515
Address
1-7 YOTSUYA, SHINJUKU-KU, TOKYO
TEL
03-3225-5138
tatsuya.kinjo@mochida.co.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Kinjo |
Organization
MOCHIDA PHARMACEUTICAL CO., LTD.
Division name
MEDICAL AFFAIRS
Zip code
160-8515
Address
1-7 YOTSUYA, SHINJUKU-KU, TOKYO
TEL
03-3225-5138
Homepage URL
tatsuya.kinjo@mochida.co.jp
Sponsor or person
Institute
MOCHIDA PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
MOCHIDA PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fuji Yakuhin Co., Ltd.
Name of secondary funder(s)
Fuji Yakuhin Co., Ltd.
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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 | 05 | Month | 19 | 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
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066196
