UMIN-CTR Clinical Trial

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

gouty or hyperuricemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Houden Clinic

Institute

Department

Personal name

Organization

SANWA KAGAKU KENKYUSHO CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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