UMIN-CTR Clinical Trial

Basic information
Public title	The effect of topirxostat on hemodialysis patient with hyperuricemia
Acronym	Topiroxostat on hemodialysis patient
Scientific Title	The effect of topirxostat on hemodialysis patient with hyperuricemia
Scientific Title:Acronym	Topiroxostat on hemodialysis patient
Region	Japan

Condition
Condition	hyperuricemia
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of topiroxostat on hyperuricemia in HD patient
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	serum uric acid
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
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	topiroxostat
Interventions/Control_2	allopurinol
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	hyperuricemia in hemodialysis
Key exclusion criteria	uric acid disorder
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshihiko Kanno
Organization	Tokyo Medical University
Division name	Department of Nephrology
Zip code
Address	6-7-1 NishiShinjuku, Shinjuku
TEL	0333426111
Email	kannoyh@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshihiko KANOO
Organization	TMU
Division name	Dept of Nephrology
Zip code
Address	6-7-1 NishiShinjuku, Shinjuku
TEL	0333426111
Homepage URL
Email	kannoyh@tokyo-med.ac.jp

Sponsor
Institute	TMU
Institute
Department

Funding Source
Organization	TMU
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 03 Month 21 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2014 Year 06 Month 03 Day
Date of IRB	2014 Year 06 Month 03 Day
Anticipated trial start date	2014 Year 06 Month 03 Day
Last follow-up date	2018 Year 04 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 21 Day
Last modified on	2020 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030575