UMIN-CTR Clinical Trial

Basic information
Public title	Study on the influence of Topiroxostat on renal function
Acronym	Study on the influence of Topiroxostat on renal function
Scientific Title	Study on the influence of Topiroxostat on renal function
Scientific Title:Acronym	Study on the influence of Topiroxostat on renal function
Region	Japan

Condition
Condition	hyperuricemia
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare indices of kidney function before and after Topiroxostat administration, clarify the effect of Topiroxostat on renal function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	eGFR change amount from pre-administration value 6 months after administration
Key secondary outcomes	Change rate of eGFR Amount of change in urine albumin Serum uric acid Adverse event

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients diagnosed as hyperuricemia 2. Patients with hyperuricemia who have already administered topiroxostat more than 6 months at the start of the study 3. Patients who have test results of eGFR value or age, sex, serum creatinine value necessary for calculation of eGFR within 3 months before and after start of administration of topiroxostat
Key exclusion criteria	1. Patients with history of hemodialysis or peritoneal dialysis within 3 months before or after the administration of topiroxostat, or before eGFR of less than 30, or before the start date of topioxastat administration 2. Patients taking other uric acid-lowering drugs (Febuxostat, Allopurinol, Benzbromarone, Probenecid, Bucolome) (including switching from other uric acid lowering drugs)
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Sato
Organization	Sato Clinic
Division name	Internal medicine ,gastrointestinal medicine
Zip code	150-0013
Address	4-28-5 Ebisu,shibuya-ku,Tokyo
TEL	03-5447-2477
Email	yasuo@sato-clinic.tokyo

Public contact
Name of contact person	1st name Yasuo Middle name Last name Sato
Organization	Sato Clinic
Division name	Internal medicine ,gastrointestinal medicine
Zip code	150-0013
Address	4-28-5 Ebisu,shibuya-ku,Tokyo
TEL	03-5447-2477
Homepage URL
Email	yasuo@sato-clinic.tokyo

Sponsor
Institute	Sato Clinic
Institute
Department

Funding Source
Organization	Fuji Yakuhin Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitamachi Clinic
Address	1-1-3 Kichijoji Kitamachi, Musashino City, Tokyo
Tel	070-5011-8550
Email	shingo-namiki@j-smo.com

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 09 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	59
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	Main results already published
Date of protocol fixation	2018 Year 06 Month 14 Day
Date of IRB	2018 Year 07 Month 17 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2018 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a cohort study conducted on patients administered topiroxostat. We extract and utilize only the items necessary for this research only from data obtained in usual routine practice.

Management information
Registered date	2018 Year 09 Month 13 Day
Last modified on	2019 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038321