UMIN-CTR Clinical Trial

Public title

Examination of the effect of a combination of benzbromarone and febuxostat in patients with hyperuricemia complicating diabetic nephropathy

Acronym

Examination of the effect of a combination of benzbromarone and febuxostat in patients with hyperuricemia complicating diabetic nephropathy

Scientific Title

Examination of the effect of a combination of benzbromarone and febuxostat in patients with hyperuricemia complicating diabetic nephropathy

Scientific Title:Acronym

Examination of the effect of a combination of benzbromarone and febuxostat in patients with hyperuricemia complicating diabetic nephropathy

Region

Japan

Condition

hyperuricemia
Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In this research, the combination therapy of febuxostat and benzbromarone, a uricosuric agent, will be administered to patients with hyperuricemia complicating diabetic nephropathy to examine the efficacy and safety of the combination therapy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

improvement of hyperuricemia

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients with hyperuricemia (serum uric acid level &#8805; 8 mg/dL) complicating diabetic nephropathy [stage 3A (GFR < 60 mL/minute/1.73 m2, proteinuria < 1 g/day) or stage 3B (GFR < 60 mL/minute/1.73 m2, proteinuria &#8805; 1 g/day)], who have failed to control the serum uric acid level at 6.0 mg/dL or lower even with 20 mg/day of febuxostat administered orally for at least 4 weeks and who have provided consent to participate in this research will be divided into 2 groups. The febuxostat dose will be increased to a maximum of 40 mg/day in the febuxostat dose-increase group and will be started at 25 mg/day and increased to a maximum of 50 mg/day in the benzbromarone combination group.

Interventions/Control_2

Patients with hyperuricemia (serum uric acid level &#8805; 8 mg/dL) complicating diabetic nephropathy who have failed to control serum uric acid level at 6.0 mg/dL or lower even after taking febuxostat at 20 mg/day for at least 4 weeks.

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 with hyperuricemia (serum uric acid level &#8805; 8 mg/dL) complicating diabetic nephropathy who have failed to control serum uric acid level at 6.0 mg/dL or lower even after taking febuxostat at 20 mg/day for at least 4 weeks.

Key exclusion criteria

(1) Patients contraindicated for benzbromarone, including
1) patients with hepatic disorders [ALT (GPT) &#8805; 100 IU/L],
2) patients with renal calculus and/or with severe renal function impairment (diabetic nephropathy stage 4 or more severe),
3) pregnant or possibly pregnant women, and
4) patients with a history of hypersensitivity to any ingredient of the product;

(2) Patients contraindicated for febuxostat, including
1) patients with a history of hypersensitivity to any ingredient of the product and
2) patients on treatment with mercaptopurine hydrate or azathioprine; and

(3) Other patients judged inappropriate by the physician in charge.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Katsumi Iizuka

Organization

Gifu university hospital

Division name

Department of diabetes and metabolism

Zip code

Address

1-1 yanagido, Gifu

TEL

+81-58-230-6377

Email

kiizuka@gifu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Katsumi Iizuka

Organization

Gifu university hospital

Division name

Department of diabetes and meatbolism

Zip code

Address

1-1 yanagido, Gifu

TEL

+81-58-230-6377

Homepage URL

Email

kiizuka@gifu-u.ac.jp

Institute

Gifu University hospital

Institute

Department

Personal name

Organization

Torii Pharmaceutical 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

2013

Year

12

Month

19

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

Enrolling by invitation

Date of protocol fixation

2013

Year

03

Month

07

Day

Date of IRB

Anticipated trial start date

2014

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

12

Month

19

Day

Last modified on

2013

Year

12

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014765