UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034118 |
|---|---|
| Receipt number | 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 | 2019/07/31 11:16:39 |
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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
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
yasuo@sato-clinic.tokyo
Sponsor or person
Institute
Sato Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038321
