UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039120 |
|---|---|
| Receipt number | 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 | 2022/07/27 13:29:10 |
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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
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
koto.hua.retro@sa-tt.co.jp
Sponsor or person
Institute
Koto Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044615
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