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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039120
Receipt No. R000044615
Scientific Title Study on effect of topiroxostat administration on serum creatinine level in patients with hyperuricemia.
Date of disclosure of the study information 2020/01/10
Last modified on 2021/01/15

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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
Publication of results Unpublished

Result
URL related to results and publications
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
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
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
2021 Year 01 Month 15 Day


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

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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