UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038238 |
|---|---|
| Receipt number | R000043543 |
| Scientific Title | Effect of topiroxostat on diabetic nephropathy in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2019/10/08 |
| Last modified on | 2020/07/22 17:15:40 |
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Basic information
Public title
Effect of topiroxostat on diabetic nephropathy in patients with type 2 diabetes mellitus
Acronym
Effect of topiroxostat on diabetic nephropathy in patients with type 2 diabetes mellitus
Scientific Title
Effect of topiroxostat on diabetic nephropathy in patients with type 2 diabetes mellitus
Scientific Title:Acronym
Effect of topiroxostat on diabetic nephropathy in patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus, hyperuricemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess changes in albuminuria in diabetic nephropathy by use of topiroxostat
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in urine albumin-to-creatinine ratio(24 weeks apart)
Key secondary outcomes
blood pressure, eGFR, serum uric acid, AST, ALT, adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
topiroxostat
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.type 2 diabetes patients who have never used antihypeuricemics
2.UA>7.0mg/dL(patients who have experienced gout or have gout nodules) or UA>=8.0mg/dL(patients with asymptomatic hyperuricemia)
3.blood pressure<140/90mmHg
4.eGFR>=30mL/min/1.73m2
5.HbA1c<10%
Key exclusion criteria
1.patients with pregnancy
2.patients with severe infection or trauma, or under surgery
3.patients who have alcohol-induced liver injury
4.patients whose general conditions are seriously ill
5.patients who are allergic to antihyperuricemics
6.patients with serious commodities or who are judged not to be suitable for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takanari |
| Middle name | |
| Last name | Kitazono |
Organization
Graduate School of Medical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
092-642-5256
kitazono@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Udai |
| Middle name | |
| Last name | Nakamura |
Organization
Kyushu University hospital
Division name
Department of Nephrology, Hypertension, and Strokology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
092-642-5256
Homepage URL
uday@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
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
Section of IRB & Ethics Committee Administration, Academic Research Support Division, Kyushu University Hospital
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
九州大学病院(福岡県)、製鉄記念八幡病院(福岡県)、福岡東医療センター(福岡県)、福岡赤十字病院(福岡県)、白十字病院(福岡県)、九州中央病院(福岡県)、聖マリア病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 08 | 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
| 2019 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 10 | Month | 08 | Day |
Last modified on
| 2020 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043543
