UMIN-CTR Clinical Trial

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