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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039985
Receipt No. 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

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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
Email 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
Email tpm-com@umin.ac.jp

Sponsor
Institute Teijin Pharma Limited
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045590

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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