UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044642 |
|---|---|
| Receipt number | R000050934 |
| Scientific Title | Study of the influence of prolonged administration of topiroxostat and control of serum uric acid level on renal function in hyperuricemia patients |
| Date of disclosure of the study information | 2021/06/24 |
| Last modified on | 2022/01/20 16:40:46 |
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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
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
hua@sa-tt.co.jp
Sponsor or person
Institute
Medical corporation jyosuikai Shimada hospital
Hidetaka Shimada
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050934
