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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031708
Receipt No. 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 2018/03/13

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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
Middle name
Last name Yasuo Terauchi
Organization Yokohama City University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2800
Email terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Okuyama
Organization Yokohama City University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2800
Homepage URL
Email oku_tomo@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 13 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
2018 Year 03 Month 13 Day
Last modified on
2018 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036170

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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