UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023584
Receipt number 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 09:04:19

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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 or person

Institute

Houden Clinic

Institute

Department

Personal name



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

Value
https://center6.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