UMIN-CTR Clinical Trial

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
Email	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
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	YCU Center for Novel and Exploratory Clinical Trials
Address	1-1-1 Fukuura, Kanazawa-ku, Yokohama
Tel	045-370-7933
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036170