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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023584
Receipt No. R000027162
Scientific Title Evaluating Safety and efficacy in retrospective ANAlysis after switching Drug to topiroxostat Among patients with hyperuricemia study
Date of disclosure of the study information 2016/08/10
Last modified on 2018/02/10

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Basic information
Public title Evaluating Safety and efficacy in retrospective ANAlysis after switching Drug to topiroxostat Among patients with hyperuricemia study
Acronym Evaluating Safety and efficacy in retrospective ANAlysis after switching Drug to topiroxostat Among patients with hyperuricemia study
(SANADA study)
Scientific Title Evaluating Safety and efficacy in retrospective ANAlysis after switching Drug to topiroxostat Among patients with hyperuricemia study
Scientific Title:Acronym Evaluating Safety and efficacy in retrospective ANAlysis after switching Drug to topiroxostat Among patients with hyperuricemia study
(SANADA study)
Region
Japan

Condition
Condition gouty or hyperuricemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this retrospective study, patients underwent treatment of hyperuricemia using topiroxostat for the first time at this clinic, or switched from allopurinol or febuxostat to topiroxostat and lasted for 12 weeks or longer are to be studied for the efficacy and safety of topiroxostat.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changed amount in L-FABP values from baseline to the week 24
Key secondary outcomes 1. Changed amount and rate from baseline to the week 24 in the values listed below:
* Marker of renal function, such as albumin/creatinine ratio (ACR), beta 2-microglobulin (beta 2-MG) , urinary N/acetyl/beta/D/glucosaminidase (NAG) , cystatine C, and eGFR
* BNP
* remnant-like lipoprotein particle cholesterol (RLPC)
* hs-CRP
* Xanthine oxidoreductase
* Xanthine
* Hypoxanthin
* IMT
* PWV
* Other, vital, general blood test, urine test

2. Incidence rate of AE, such as gouty arthritis

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 Patients who meet all of the following criteria are included in this study.
1. Patients undergone treatment for either gout or hyperuricemia in the clinic from January 2015 to March 2016
2. Patients newly started topiroxostat treatment, or switched to topiroxostat treatment from allopurinol or febuxostat and continued the topiroxostat for at least 12 weeks
3. Patients at age of 20 or older when giving their consent
4. Patients who can provide their consent in a written form
Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study.
1. Patients who is hypersensitive to topiroxostat, febuxostat, or allopurinol
2. Dehydrated patients or patients with impairment in drinking water
3. Patients with rheumatic disease
4. Patients with COPD
5. Patients with idiopathic thrombocytopenic purpura (ITP)
6. Patients taking pyrazinamide or ethambutol while giving their samples
7. Patients taking mizoribine or cyclosporine while giving their samples
8. Patients taking mercaptopurine hydrate, or azathioprine while giving their samples
9. Patients taking xanthine-based medicine while giving their samples
10. Patients taking non-steroidal anti-inflammatory/NSAIDs drug while giving their samples
11. Other conditions that a physician thinks inappropriate to participate in the study

Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Tohyo
Organization Houden Clinic
Division name Internal medicine, gastrointestinal medicine, cardiovascular medicine
Zip code
Address 250-4 Tonoshiro, Uedashi, Nagano
TEL 0268-29-1220
Email hodenmc@ued.janis.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute Houden Clinic
Institute
Department

Funding Source
Organization SANWA KAGAKU KENKYUSHO 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
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
2016 Year 08 Month 10 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 Completed
Date of protocol fixation
2016 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:
Retrospective, explanatory, noninvasive, open-label, clinical study

Study methods:
This retrospective study collects data of patients via the electronic carte in Houden Clinic

Data collection period:
Data of patients who visited Houden Clinic during January 2015 to the end of March 2016, underwent topiroxostat treatment for 24 weeks (allowance: -4 to +4 weeks) counting from the commencement* of topiroxostat, and met all the inclusion criteria are collected for the study.

*Baseline is the date of starting topiroxostat treatment. If the first day of using topiroxostat is not dated, it can be replaced by the closest date of administering the medication (However, the data collecting period should stay within a window of 24 weeks [allowance: -4 weeks to +4 weeks] counting from baseline).

Observation items:
In addition to primary and secondary endpoints, background information of patients and data regarding all medications including the dosage of topiroxostat are collected.

Management information
Registered date
2016 Year 08 Month 10 Day
Last modified on
2018 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027162

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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