UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022644 |
|---|---|
| Receipt number | R000025804 |
| Scientific Title | The effect of topiroxostat on renal function in type2 diabetes with hyperuricemia |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2016/06/07 16:27:15 |
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Basic information
Public title
The effect of topiroxostat on renal function in type2 diabetes with hyperuricemia
Acronym
The effect of topiroxostat on renal function in type2 diabetes with hyperuricemia
Scientific Title
The effect of topiroxostat on renal function in type2 diabetes with hyperuricemia
Scientific Title:Acronym
The effect of topiroxostat on renal function in type2 diabetes with hyperuricemia
Region
| Japan |
Condition
Condition
type 2 diabetes with serum uric acid levels more than 7 mg/dl and eGFR more than 60 mL/min/1.73m2
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether measured GFR changes byoral administration of Topiroxostat,or not.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of measured GFR by topiroxostat (40 mg/day) administration in 7 days
Key secondary outcomes
Change in serum uric acid levels, albuminuria, xanthine oxidoreductase by topiroxostat(40mg/day) administration in 7 days
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
We measure clearance of para-aminohippurate and inulin in subjects had diabetes.
after measurement,subjects take topiroxostat after breakfast and dinner twice a day for one week.And we measure clearance of para-aminohippurate and inulin again.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Hyperuricemia
2) eGFR more than 60mL/min/1.73m2
3) diabees patients who were admitted to the Diabetes Center of the Osaka City University Hospital
4) The patients who were obtained written informed consent by free will after enough explanation.
Key exclusion criteria
1) age more than 80 years or less than 20years
2) The patients who has malignant disease
3) The patients who has heavy heart failer or unstable angina
4) The patients who has heavy hepatic failer (AST or ALT more than 100U)
5) The patients who has renal failure
6) The patients who has past history of gout attack or who is already taking a therapeutic drug of the hyperuricemia
7) The patients who take a medicine which
prohibited to taken with topiroxostat
8) Pregnancy planned woman,Pregnant woman,The woman whom I am nursing
9) The patient who has an allergy career to a study drug
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Tsuda |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Endocrinology, Metabolism and Molecular Medicine,
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3806
narano-tsudadesu@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tsuda |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Endocrinology, Metabolism and Molecular Medicine,
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3806
Homepage URL
narano-tsudadesu@umin.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪市立大学医学部附属病院/osaka city university of medicine
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 15 | 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
| 2016 | Year | 06 | Month | 07 | Day |
Last modified on
| 2016 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025804
