UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026765 |
|---|---|
| Receipt number | R000030728 |
| Scientific Title | Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat on serum uric acid, endothelial function and markers for kidney injury |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2023/04/05 10:19:06 |
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Basic information
Public title
Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat on serum uric acid, endothelial function and markers for kidney injury
Acronym
Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat.
Scientific Title
Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat on serum uric acid, endothelial function and markers for kidney injury
Scientific Title:Acronym
Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat.
Region
| Japan |
Condition
Condition
Hyperuremia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of topiroxostat versus febuxostat on uric acid and endothelial function in hyperuremic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow-mediated vasodilation in forearm, serum level of uric acid, marker of early-staged kidney diseases 12 weeks after administration
Key secondary outcomes
Serum level of lipid, glucose, HbA1c and liver function, Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL),
12 weeks after administration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Topiroxostat 40-160mg /day for 12 weeks
> Febuxostat 10-40mg /day for 12 weeks
Interventions/Control_2
Febuxostat 10-40mg/day for 12 weeks
> Topiroxostat 40-160mg/day for 12 weeks
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Poor-controlled hyperuricemia despite adequate lifestyle improvement for 8 weeks.(UA>8mg/dl)
2) 20 years of age or more
3) female or male
4) outpatients
5) eGFR>30ml/min./1.73m2
6) Subjects who can get the consent to join this study
Key exclusion criteria
1) Subjects who has a history of allergy to topiroxostat or febuxostat.
2) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
3) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
4) Subjects who has already taken mercaptopurine hydrate, azathioprine, vidarabine, didanosine.
5) Subjects whose doctor in charge do not agree to join the trial
6) Subjects who has past medical histories of active hemorrhage, ulcer, stroke, optical hemorrhage, hemorrhagic tendency.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Ezaki |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
359-1142
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN
TEL
04-2940-8611
hirotakaezaki@gmail.com
Public contact
Name of contact person
| 1st name | Misa |
| Middle name | |
| Last name | Ito |
Organization
Self-Defense Forces Fuji Hospital
Division name
Department of Internal Medicine
Zip code
410-1431
Address
481-27 Subashiri, Oyama, Shunto, Shizuoka, Japan 410-1431
TEL
0550-75-2311
Homepage URL
jumpimjumpim@gmail.com
Sponsor or person
Institute
Tokorozawa Heart Center
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Self-Defense Forces Fuji Hospital
National defense medical college hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Tokorozawa Heart Center
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, Japan
Tel
04-2940-8611
cs.thc@oukai.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
| 2017 | Year | 03 | Month | 30 | 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
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030728
