UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031708 |
|---|---|
| Receipt number | R000036170 |
| Scientific Title | The efficacy of febuxostat or topiroxostat on nephropathy in type 2 diabetes with hyperuricemia: A randomized clinical trial |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2020/09/27 09:06:07 |
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Basic information
Public title
The efficacy of febuxostat or topiroxostat on nephropathy in type 2 diabetes with hyperuricemia: A randomized clinical trial
Acronym
The efficacy of febuxostat or topiroxostat on diabitic nephropathy: A randomized clinical trial
Scientific Title
The efficacy of febuxostat or topiroxostat on nephropathy in type 2 diabetes with hyperuricemia: A randomized clinical trial
Scientific Title:Acronym
The efficacy of febuxostat or topiroxostat on diabitic nephropathy: A randomized clinical trial
Region
| Japan |
Condition
Condition
Type 2 diabetes with hyperuricemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of febuxostat with topiroxostat on diabetic nephropathy in type 2 diabetes with hyperuricemia.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement in urinary alubumin creatinine ratio after 24 weeks of treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Febxostat 10mg/day for 24 weeks
Interventions/Control_2
Topiroxostat 40mg/day for 24 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with type 2 diabetes, who has diabetic nephropaty.
2)Patients diagnosed hyperuricemia.
3)Aged over 20.
4)Having provided voluntary written consent for participation in this study.
Key exclusion criteria
1)Patients whose baseline eGFR were <30 ml/min/1.73m^2.
2)Patients treated with uric acid synthesis inhibitors or uricosuric drugs.
3)Patients with severe infections.
4)Patients who are receiving chemotherapy with malignancy.
6)Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Terauchi |
Organization
Yokohama City University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2800
terauchi@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Okuyama |
Organization
Yokohama City University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2800
Homepage URL
oku_tomo@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Kanae foundation for the promotion of medical science
Suzuken memorial foundation
Tokyo future medical forum
MSD
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
YCU Center for Novel and Exploratory Clinical Trials
Address
1-1-1 Fukuura, Kanazawa-ku, Yokohama
Tel
045-370-7933
rinri@yokohama-cu.ac.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
| 2018 | Year | 03 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 13 | Day |
Last modified on
| 2020 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036170
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
