UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of characteristics and prescription status and occurrence of cardiovascular and renal disease events in patients with hyperuricemia or gout
Acronym	Investigation of various conditions in patients with hyperuricemia or gout
Scientific Title	Investigation of characteristics and prescription status and occurrence of cardiovascular and renal disease events in patients with hyperuricemia or gout
Scientific Title:Acronym	Investigation of various conditions in patients with hyperuricemia or gout
Region	Japan

Condition
Condition	Hyperuricemia or gout
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the specific characteristics and prescription status of individuals who were firstly diagnosed with hyperuricemia or gout, as well as the occurrence of cardiovascular and renal disease events, and to examine the impact of uric acid-lowering drugs on the occurrence of cardiovascular and renal events.
Basic objectives2	Others
Basic objectives -Others	Survey of actual conditions
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Patient characteristics and treatment status
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Database registrations within the total data period. 2. Continuing contract with the health insurance association in which they participated at the end of the total data period. 3. The first (oldest) diagnosis of hyperuricemia or gout (referred to as the index diagnosis) was within the inclusion period. 4. Twelve months of observations were available retrospectively from the time of the index diagnosis. 5. No record of ULD prescription prior to the index diagnosis. 6. Age over 20 years at the index diagnosis.
Key exclusion criteria	None
Target sample size	60000

Research contact person
Name of lead principal investigator	1st name Seigo Middle name Last name Akari
Organization	Sanwa Kagaku Kenkyusho Co.,Ltd.
Division name	Medical Affairs Department
Zip code	461-8631
Address	35 Higashisotobori-cho,Higashi-ku, Nagoya
TEL	052-951-8130
Email	s_akari@skk-net.com

Public contact
Name of contact person	1st name Seigo Middle name Last name Akari
Organization	Sanwa Kagaku Kenkyusho Co.,Ltd.
Division name	Medical Affairs Department
Zip code	461-8631
Address	35 Higashisotobori-cho,Higashi-ku, Nagoya
TEL	052-951-8130
Homepage URL
Email	s_akari@skk-net.com

Sponsor
Institute	Medical Affairs Department, Sanwa Kagaku Kenkyusho Co., Ltd.
Institute
Department

Funding Source
Organization	Sanwa Kagaku Kenkyusho Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Institute of Healthcare Data Science
Address	Sumitomo Shiba-Daimon Building 12F, 2-5-5 Shiba-Daimon, Minato-ku, Tokyo
Tel	03-5733-5010
Email	rihds@jmdc.co.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	2021 Year 09 Month 10 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	64677
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 07 Month 15 Day
Date of IRB	2020 Year 08 Month 31 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 09 Month 08 Day
Last modified on	2022 Year 05 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051866