UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034118
Receipt No. R000038321
Scientific Title Study on the influence of Topiroxostat on renal function
Date of disclosure of the study information 2018/09/25
Last modified on 2019/03/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Unpublished

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 Completed
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 03 Month 19 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.