UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000022644
Receipt number	R000025804
Scientific Title	The effect of topiroxostat on renal function in type2 diabetes with hyperuricemia
Date of disclosure of the study information	2016/06/15
Last modified on	2016/06/07 16:27:15

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Basic information

Public title

The effect of topiroxostat on renal function in type2 diabetes with hyperuricemia

Acronym

The effect of topiroxostat on renal function in type2 diabetes with hyperuricemia

Scientific Title

The effect of topiroxostat on renal function in type2 diabetes with hyperuricemia

Scientific Title:Acronym

The effect of topiroxostat on renal function in type2 diabetes with hyperuricemia

Region

Japan

Condition

type 2 diabetes with serum uric acid levels more than 7 mg/dl and eGFR more than 60 mL/min/1.73m2

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To examine whether measured GFR changes byoral administration of Topiroxostat,or not.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

The change of measured GFR by topiroxostat (40 mg/day) administration in 7 days

Key secondary outcomes

Change in serum uric acid levels, albuminuria, xanthine oxidoreductase by topiroxostat(40mg/day) administration in 7 days

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

No need to know

Intervention

No. of arms

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

We measure clearance of para-aminohippurate and inulin in subjects had diabetes.
after measurement,subjects take topiroxostat after breakfast and dinner twice a day for one week.And we measure clearance of para-aminohippurate and inulin again.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Hyperuricemia
2) eGFR more than 60mL/min/1.73m2
3) diabees patients who were admitted to the Diabetes Center of the Osaka City University Hospital
4) The patients who were obtained written informed consent by free will after enough explanation.

Key exclusion criteria

1) age more than 80 years or less than 20years
2) The patients who has malignant disease
3) The patients who has heavy heart failer or unstable angina
4) The patients who has heavy hepatic failer (AST or ALT more than 100U)
5) The patients who has renal failure
6) The patients who has past history of gout attack or who is already taking a therapeutic drug of the hyperuricemia
7) The patients who take a medicine which
prohibited to taken with topiroxostat
8) Pregnancy planned woman,Pregnant woman,The woman whom I am nursing
9) The patient who has an allergy career to a study drug

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Akihiro Tsuda

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Endocrinology, Metabolism and Molecular Medicine,

Zip code

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

TEL

06-6645-3806

Email

narano-tsudadesu@umin.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Akihiro Tsuda

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Endocrinology, Metabolism and Molecular Medicine,

Zip code

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

TEL

06-6645-3806

Homepage URL

Email

narano-tsudadesu@umin.ac.jp

Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name

Funding Source

Organization

nothing

Organization

Division

Category of Funding Organization

Other

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪市立大学医学部附属病院/osaka city university of medicine

Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 15 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

Preinitiation

Date of protocol fixation

2016 Year 06 Month 15 Day

Date of IRB

Anticipated trial start date

2016 Year 06 Month 15 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2016 Year 06 Month 07 Day

Last modified on

2016 Year 06 Month 07 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025804

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name