UMIN-CTR Clinical Trial

Public title

The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia in chronic kidney disease.

Acronym

The effects and safety of febuxostat in chronic kidney disease.

Scientific Title

The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia in chronic kidney disease.

Scientific Title:Acronym

The effects and safety of febuxostat in chronic kidney disease.

Region

Japan

Condition

Hyperuricemic patients with CKD

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia in chronic kidney disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1) Serum Uric acid
2) Serum Cr, eGFR
3) Derum systatin C

Key secondary outcomes

1) Urinary protein/Cr ratio
2) Urinary tubular markers/Cr ratio
3) Urinary uric acid excretion ratio

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1)Febuxostat group
CKD patients with hyperuricemia (Uric acid more than 6mg/dl) are scheduled to treat with 10 mg/day of febuxostat in the beginnings. The doses of febxostat are allowed to increase until 40mg/day, if the serum levels of uric acid were not controlled to the target values.

Interventions/Control_2

2)Allopurinol group
CKD patients with hyperuricemia (Uric acid more than 6mg/dl) are scheduled to treat with 50mg/day of allopurinol in the beginnings. The dose of allopurinol is allowed to increase until 200mg/day, when the eGFR of the patients were equal or more than 50 ml/min/1.73m2. Similarly, the dose of allopurinol is allowed to increase until 100mg/day, when the eGFR of the patients were between 30 and 50 ml/min/1.73m2.

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

1)adult(older than 19 years-old)
2)regardless of gender
3)Uric acid equal and more than 8mg/dl and the eGFR of less than 60ml/min/1.73m2
4)The general condition of the participants need to be stable. The participants should be treated according to the CKD practice guideline except uric acid treatment
5) Written informed consent should be obtained by all participants.

Key exclusion criteria

1.The patients who are contraindicated
to use febuxostat or allopurinol.
1)Patients who have liver injury(The ALT more than 200 IU/L)
2) Woman who is pregnat.
3) Patients who have allergy to febuxostat or allopurinol.
2. Patients who are judged as
inadequate to participate the study by the their doctors.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Nobuhito Hirawa

Organization

Yokohama City University Medical Center

Division name

Department of hemodialysis and apheresis

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

Name of contact person

1st name
Middle name
Last name	Nobuhito Hirawa

Organization

Yokohama City University Medical Center

Division name

Department of hemodialysis and apheresis

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL

Email

hirawa@yokohama-cu.ac.jp

Institute

Yokohama City University Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

横浜市立大学附属市民総合医療センター（神奈川県）

Date of disclosure of the study information

2011

Year

05

Month

16

Day

URL releasing protocol

Publication of results

Published

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

2011

Year

03

Month

24

Day

Date of IRB

Anticipated trial start date

2011

Year

05

Month

01

Day

Last follow-up date

2016

Year

04

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

05

Month

09

Day

Last modified on

2013

Year

11

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006596