UMIN-CTR Clinical Trial

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
Email	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
Email	uday@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043543