UMIN-CTR Clinical Trial

Basic information
Public title	Study on effect of topiroxostat administration on serum creatinine level in patients with hyperuricemia.
Acronym	Study on effect of topiroxostat administration on serum creatinine level in patients with hyperuricemia.
Scientific Title	Study on effect of topiroxostat administration on serum creatinine level in patients with hyperuricemia.
Scientific Title:Acronym	Study on effect of topiroxostat administration on serum creatinine level in patients with hyperuricemia.
Region	Japan

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

Objectives
Narrative objectives1	A retrospective study will be conducted on the effect on serum creatinine and other laboratory values in patients with hyperuricemia administered topiroxostat for at least 1 year from January 1, 2015 to October 31, 2019.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in serum creatinine level from treatment initiation to the last assessment time point.
Key secondary outcomes	(1) Serum creatinine level 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (2) Serum uric acid level 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (3) BUN 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (4) eGFR 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (5) AST, ALT Change from treatment initiation at each time point (6) TG, HDL-C, LDL-C Change from treatment initiation at each time point (7) HbA1c Change from treatment initiation at each time point (8) Safety assessment The occurrence of adverse events and adverse drug reactions during the topiroxostat treatment period will be assessed.

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) Patient took topiroxostat for at least 1 year (2) Patient aged at least 20 years on treatment initiation date
Key exclusion criteria	(1) Patient has serious liver or kidney disease at initiation of topiroxostat treatment (2) Patient undergoing hemodialysis or has undergone kidney transplantation at initiation of topiroxostat treatment (3) Patient has comorbid malignancy at initiation of topiroxostat treatment (4) Patient coadministered another urate-lowering drug at initiation of topiroxostat treatment (5) Patient deemed unsuitable for participation in this research by the investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Eiji Middle name Last name Tamiya
Organization	Koto Hospital
Division name	Cardiology
Zip code	136-0072
Address	6-8-5,Ojima,Koto-ku,Tokyo,Japan
TEL	03-3685-7500
Email	koto.hua.retro@sa-tt.co.jp

Public contact
Name of contact person	1st name Kousaku Middle name Last name Kawada
Organization	Satt Co.,Ltd
Division name	Project Management-Team
Zip code	160-0022
Address	5F,ACN-Shinjuku Building,2-12-8, Shinjuku,Shinjuku-ku,Tokyo
TEL	03-5312-5026
Homepage URL
Email	koto.hua.retro@sa-tt.co.jp

Sponsor
Institute	Koto Hospital
Institute
Department

Funding Source
Organization	FUJI YAKUHIN 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	Koto Hospital ethics committee
Address	6-8-5,Ojima,Koto-ku,Tokyo,Japan
Tel	03-3685-7500
Email	soumu-s@koto-hospital.or.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 01 Month 10 Day

Related information
URL releasing protocol	https://link.springer.com/article/10.1007/s40801-022-00291-w
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s40801-022-00291-w
Number of participants that the trial has enrolled	104
Results	After 12 months, sUA significantly decreased, but. sCr and eGFR showed slightly non-significant changes from the baseline. sCr were significantly increased during 6 months before topiroxostat administration (p < 0.001) but showed no significant change at 6 months after topiroxostat treatment (p = 0.682).
Results date posted	2021 Year 01 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 01 Month 29 Day
Baseline Characteristics	Data from 103 patients were extracted. Of these, three patients were excluded from the tabulation because of duplicate entries, violation of exclusion criteria 3 or 4, or failure to meet inclusion criteria 1. The 100 patients were 77.2+-9.5 years old (50 to 95 years old), 67 males and 33 females. The prevalence of complications included 95% hypertension, 73% chronic kidney disease, and 46% atrial fibrillation. Chronic kidney disease grade 3 (G3) accounted for 77% of patients. The uric acid-lowering drugs administered before topiroxostat were allopurinol in 30 patients (mean dose, 108.3 purasumainasu 32.4 mg), febuxostat in 12 patients (16.7+-11.5 mg), and benzbromarone in two patients (50.0 mg), and hyperuricemia was untreated in 56 patients.
Participant flow	A total of 104 patients were enrolled in the study. Of these, four patients were excluded from the analysis because of duplicate entries, violation of exclusion criteria 3 or 4, or failure to meet inclusion criteria 1.
Adverse events	In the 103 patients whose data were extracted for the present analysis, there were no adverse events after the administration of topiroxostat for which a relationship to topiroxostat could not be ruled out.
Outcome measures	This retrospective analysis of medical information showed that topiroxostat significantly reduced sUA levels in elderly patients with hyperuricemia associated with decreased renal function. There was no significant increase in sCr after treatment with topiroxostat. Changes in sCr and eGFR 6 months before the administration of topiroxostat until baseline exhibited decreased renal function.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 11 Month 06 Day
Date of IRB	2020 Year 11 Month 06 Day
Anticipated trial start date	2020 Year 01 Month 10 Day
Last follow-up date	2020 Year 02 Month 28 Day
Date of closure to data entry	2020 Year 02 Month 28 Day
Date trial data considered complete	2020 Year 03 Month 10 Day
Date analysis concluded	2020 Year 04 Month 30 Day

Other
Other related information	none

Management information
Registered date	2020 Year 01 Month 10 Day
Last modified on	2022 Year 07 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044615