UMIN-CTR Clinical Trial

Basic information
Public title	Study of the influence of prolonged administration of topiroxostat and control of serum uric acid level on renal function in hyperuricemia patients
Acronym	Top real
Scientific Title	Study of the influence of prolonged administration of topiroxostat and control of serum uric acid level on renal function in hyperuricemia patients
Scientific Title:Acronym	Top real
Region	Japan

Condition
Condition	Hyperuricemia
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to retrospectively evaluate the effect of serum uric acid level on eGFR in patients with hyperuricemia treated with topiroxostat for at least 24 months between January 1, 2015 and April 30, 2021.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Patients will be divided into 2 groups: Low group (patients with a mean uric acid level of 6 mg/dl or less for 6 months or longer at 12 months or later) and High group (those other than the above). The change in eGFR from baseline to the final evaluation at 24 months will be compared.
Key secondary outcomes	(1)Uric acid level 1)Change from baseline to 24 months(by GFR category*) (2)Serum creatinine level 1)Change from baseline to 24 months 2)Doubling rate from baseline to 24 months(by uric acid level*) (3)eGFR 1)Change from baseline to 24 months 2)Change from baseline to 24 months(by GFR category) 3)30% reduction rate from baseline to 24 months(by uric acid level) *By GFR category: GFR category at baseline(G3a, G3b, G4, G5) *By uric acid level: The uric acid value at baseline is divided into 6 groups(<6.0,6.0-6.9,7.0-7.9,8.0-8.9,9.0-9.9,>10).

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	[Inclusion criteria] 1) Patients taking topiroxostat continuously for at least 24 months (monotherapy/combination with a uric acid-lowering drug) 2) Patients aged 20 years or over at baseline 3) Patients with eGFR <60 at baseline (CKD Grade 3 or higher)
Key exclusion criteria	[Exclusion criteria] (1) Patients with AST or ALT 100 IU/L or higher at the start of topiroxostat treatment (2) Patients with eGFR < 30 at the start of topiroxostat treatment (3) Patients receiving hemodialysis at the start of topiroxostat treatment or those who underwent kidney transplantation (4) Patients with viral hepatitis, chronic liver disease, or malignancy at the start of topiroxostat treatment (5) Patients considered inappropriate for participation in the study by the investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hidetaka Middle name Last name Shimada
Organization	Medical corporation jyosuikai Shimada hospital
Division name	Chairperson
Zip code	860-0017
Address	24, Renpeicho, Kumamoto Chuo-ku, Kumamoto
TEL	096-324-3515
Email	info@shimada-hp.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name Ishikawa
Organization	Satt Co., LTd
Division name	Clinical research group
Zip code	160-0022
Address	ACN Shinjuku building 5F, 2-12-8, Shinjuku, Shinjuku-ku, Tokyo
TEL	03-5312-5026
Homepage URL
Email	hua@sa-tt.co.jp

Sponsor
Institute	Medical corporation jyosuikai Shimada hospital Hidetaka Shimada
Institute
Department

Funding Source
Organization	Fujiyakuhin Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	medical ethics committee
Address	24, Renpeicho, Kumamoto Chuo-ku, Kumamoto
Tel	096-324-3515
Email	info@shimada-hp.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	医療法人如水会 嶋田病院（熊本県） Medical corporation jyosuikai Shimada hospital（Kumamoto）

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 24 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	75
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	2021 Year 06 Month 11 Day
Date of IRB	2021 Year 06 Month 11 Day
Anticipated trial start date	2021 Year 07 Month 02 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1)It is suggested that hyperuricemia is related to Chronic Kidney Disease(CKD)and there is a possibility for hyperuricemia to be its risk factor. 2)The evidence is insufficient to prove the possibility for antihyperuricemic to prevent CKD onset and its progression. 3)The effect of control of serum uric acid level by prolonged antihyperuricemic administration on renal function is not also clarified. 4)This study aims to evaluate the relationship between control of serum uric acid level by prolonged administration of topiroxostat as antihyperuricemic and renal function(eGFR) via collecting data of hyperuricemia patients with CKD retrospectively.

Management information
Registered date	2021 Year 06 Month 24 Day
Last modified on	2022 Year 01 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050934