UMIN-CTR Clinical Trial

Public title

Comparison of anti-proteinuric effects of febuxostat and conventional therapies for hyperuricemia in patients with chronic kidney disease: an open-label randomized controlled trial

Acronym

Reno-protective Effect of Febuxostat in Renal-dysfunctional Secondary Hyperuricemia (Tohoku REFRESH study)

Scientific Title

Comparison of anti-proteinuric effects of febuxostat and conventional therapies for hyperuricemia in patients with chronic kidney disease: an open-label randomized controlled trial

Scientific Title:Acronym

Reno-protective Effect of Febuxostat in Renal-dysfunctional Secondary Hyperuricemia (Tohoku REFRESH study)

Region

Japan

Condition

Hyperuricemia, chronic kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate anti-proteinuric effect of febuxostat in CKD patients with hyperuricemia

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Urinary protein creatinine ratio at 24 weeks after treatments

Key secondary outcomes

Chronological changes of urinary protein excretion from the baseline to 24 weeks and those from 24 to 48 weeks. Estimated GFR, plasma renin activity, plasma aldosterone concentration, urinary albumin creatinine ratio, urinary L-FABP, urinary 8-OHdG, serum methylglyoxal, and blood pressure

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Febuxostat 10-60 mg/day to target serum urate range from 4 to 6 mg/dL from the baseline to 48 weeks

Interventions/Control_2

Conventional treatments (allopurinol and/or benzbromarone, or no drug) to target serum urate range from 8 to 10 mg/dL from the baseline to 24 weeks, and febuxostat 10-60 mg/day to target serum urate range from 4 to 6 mg/dL from 24 to 48 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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Obtained written informed consent from the patient for the study participation 2) Stable condition for more than 3 months on the treatments by a nephrologist 3) Age >-20 and <80 years old 4) eGFR >-15 and <45 mL/min/1.73m2 5) Serum uric acid >-7.0 mg/dL and <11.0 mg/dL 6) Urinary protein creatinine ratio >-0.3 and <3.5 g/gCr 7) Outpatient who can visit bimonthly at least

Key exclusion criteria

1) High-risk patients requiring dialysis or renal transplantation within 48 weeks 2) History of gout 3) Patients with Cancer or liver disease (HBV/HCV hepatitis, cirrhosis, and the other liver injuries showing AST/ALT values more than twice as high of normal values 4) HbA1c (JDS) >-7.0% with 2 months prior to the entry 5) Office systolic blood pressure >-160 mmHg or diastolic blood pressure >-100 mmHg both at recent twice office visits before the entry 6) Severe heart failure or edema 7) History of renal replacement therapy 8) History of febuxostat intake within four weeks before the entry 9) History of hypersensitivity to allopurinol, benzbromarone, or febuxostat 10) Judged as ineligible in the opinion of the attending physician 11) Pregnancy or nursing

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Mariko Miyazaki

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Nephrology, Endocrinology, and Vascular Medicine

Zip code

Address

2-1 Seiryo-Cho, Aoba-Ku, Sendai 980-8574

TEL

022-717-7163

Email

Name of contact person

1st name
Middle name
Last name	Takashi Nakamichi

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Nephrology, Endocrinology, and Vascular Medicine

Zip code

Address

2-1 Seiryo-Cho, Aoba-Ku, Sendai 980-8574

TEL

022-717-7163

Homepage URL

Email

tnakamichi@med.tohokou.ac.jp

Institute

Division of Nephrology, Endocrinology, and Vascular Medicine, Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

Teijin pharma limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

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

東北大学病院（宮城県）　Tohoku University Hospital, Miyagi prefecture
岩手県立中央病院（岩手県）　Iwate Prefectural Central Hospital, Iwate prefecture

Date of disclosure of the study information

2013

Year

02

Month

15

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

2012

Year

12

Month

05

Day

Date of IRB

Anticipated trial start date

2013

Year

03

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

02

Month

03

Day

Last modified on

2013

Year

07

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011646