UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008343
Receipt number R000009817
Scientific Title FEbuxostat versus placebo rAndomized controlled Trial regarding reduced renal function in patients with Hyperuricemia complicated by chRonic kidney disease stage 3 (FEATHER study)
Date of disclosure of the study information 2012/07/04
Last modified on 2023/11/13 14:29:56

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Basic information

Public title

FEbuxostat versus placebo rAndomized controlled Trial regarding reduced renal function in patients with Hyperuricemia complicated by chRonic kidney disease stage 3 (FEATHER study)

Acronym

FEbuxostat versus placebo rAndomized controlled Trial regarding reduced renal function in patients with Hyperuricemia complicated by chRonic kidney disease stage 3 (FEATHER study)

Scientific Title

FEbuxostat versus placebo rAndomized controlled Trial regarding reduced renal function in patients with Hyperuricemia complicated by chRonic kidney disease stage 3 (FEATHER study)

Scientific Title:Acronym

FEbuxostat versus placebo rAndomized controlled Trial regarding reduced renal function in patients with Hyperuricemia complicated by chRonic kidney disease stage 3 (FEATHER study)

Region

Japan


Condition

Condition

chronic kidney disease, hyperuricemia

Classification by specialty

Medicine in general Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the preventive effect of febuxostat for hyperuricemia treatment on deteriorating renal function defined as estimation glomerular filtration rate (eGFR) in patients with chronic kidney disease stage 3

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

eGFR slope(change per year,mL/min/1.73 m2/year)

Key secondary outcomes

(1) Changes of eGFR from the baseline to 108 weeks: To evaluate the amount of change (mL/min/1.73 m2) and the rate of change (%) of eGFR from the baseline to 24, 48, 72, and 108 weeks.
(2) Changes of the serum uric acid from the baseline to 108 weeks: To evaluate the amount of change (mg/dL) and the rate of change (%) of serum uric acid from the baseline to 108 weeks.
(3) The achievement of serum uric acid level lower than 6.0 mg/dL
(4) Occurence of events indicating the deterioration of renal functions: Induction of dialysis and evaluation of the doubling of serum creatinine level.
(5) Changes of various markers from the baseline to 108 weeks i.e. exploratory examinations of the following markers of hyperuricaemia treatment for CKD patients.
Renal function (serum cystatin C), oxidative stress marker (urinary 8-OHdG, urinary L-FABP), inflammatory marker (serum CRP), cardiovascular events (12-lead electrocardiogram, serum NT-pro-BNP, the albumin urine / creatinine ratio)
(6) Incidence of gouty arthritis
(7) Incidence of adverse event


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Febuxostat group:
Patients take febuxostat by oral administration for 108 weeks (approximately two years).

The beginning dosage of study drug (febuxostat) is one 10 mg tablet/day.
The study drug is increased to one 20 mg tablet/day after four weeks from study treatments initiation.
The study drug is increased to one 40 mg tablet/day after eight weeks from study treatments initiation.
Then, administration of the study drug with one 40 mg tablet/day is maintained until 108 weeks.

Interventions/Control_2

Placebo group:
Patients take placebo by oral administration for 108 weeks (approximately two years).

The beginning dosage of study drug (placebo) is one 10 mg tablet/day.
The study drug is increased to one 20 mg tablet/day after four weeks from study treatments initiation.
The study drug is increased to one 40 mg tablet/day after eight weeks from study treatments initiation.
Then, administration of the study drug with one 40 mg tablet/day is maintained until 108 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Age 20 years-old at informed consent
(2) Patients with hyperuricaemia; serum uric acid >7.0 and 10.0 mg/dL
(3) eGFR 30 and <60 mL/min/1.73 m2 (CKD stage 3a and 3b)
(4) No history of gout
(5) Obtained written informed consent from the patient for the study participation

Key exclusion criteria

(1) Uncontrolled diabetes mellitus; HbA1c 8.0% (JDS) or 8.4% (NGSP)
(2) Systolic blood pressure 160 mmHg or diastolic blood pressure 100 mmHg
(3) ALT or AST is more than the twice the upper limit of institutional reference range
(4) Change of serum creatinine more than 50% within 12 weeks
(5) Acute renal disease, nephrotic syndrome, other serious disease, on dialysis, or renal-transplant
(6) Complication or history of malignant tumor (Patients were not excluded from the study when the malignant tumor is not treated within five years and if there is no recurrence.)
(7) History of hypersensitivity to febuxostat
(8) Intake of any of the following drug at confirmation of eligibility; mercaptopurine hydrate, azathioprine, vidarabine, didanosine
(9) Intake of any of the following uric acid descent medicine within four weeks before confirmation of eligibility; allopurinol, benzbromarone, probenecid, bucolome,febuxostat
(10) Beginning of dosage, change of dose or discontinued with any of the following drug within four weeks before confirmation of eligibility; losartan, fenofibrate, thiazide diuretics, loop diuretic
(11) Continuous intake of salicylic acid drugs such as aspirin continuously (Patients taking low-dose aspirin [324 mg/day] were not excluded from the study.)
(12) Being on hormone replacement therapy with estrogen
(13) Pregnancy, nursing or planning to become pregnant during the study
(14) Participation in other clinical trials within 24 weeks before informed consent
(15) Judged as ineligible in the opinion of the investigator

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Kenjiro Kimura/Tatsuo Hosoya
Middle name
Last name Kenjiro Kimura/Tatsuo Hosoya

Organization

Tokyo Takanawa Hospital (Kenjiro Kimura)
Jikei University School of Medicine (Tatsuo Hosoya)

Division name

Division of Chronic Kidney Disease Therapeutics (Tatsuo Hosoya)

Zip code

105-8461

Address

3-10-11, Takanawa, Minato-ku, Tokyo 108-8606, Japan (Kenjiro Kimura)/3-25-8 Shinbashi, Minato-ku, Tokyo 105-8461, Japan (Tatsuo Hosoya)

TEL

03-5287-2639

Email

feather@csp.or.jp


Public contact

Name of contact person

1st name Yoji
Middle name
Last name Mitadera

Organization

Public Health Research Foundation (PHRF)

Division name

Comprehensive Support Project for Clinical Research of Lifestyle-Related Disease (CSP-LD)

Zip code

169-0051

Address

1-1-7-3F Nishiwaseda,shinjyuku-ku,Tokyo,169-0051

TEL

03-5287-2639

Homepage URL

http://csp.or.jp/ld/feather/index.html

Email

feather@csp.or.jp


Sponsor or person

Institute

Public Health Research Foundation (PHRF)

Institute

Department

Personal name



Funding Source

Organization

TEIJIN PHARMA LIMITED

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Public Health Research Foundation

Address

1-1-7 Nishiwaseda Shinnjyuku Tokyo

Tel

03-5287-2638

Email

info-ld@csp.or.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

聖マリアンナ医科大学病院(神奈川県)、東京慈恵会医科大学附属病院(東京都)、東北大学病院(宮城県)、帝京大学医学部附属病院(東京都)、順天堂大学医学部附属順天堂医院(東京都)、名古屋大学医学部附属病院(愛知県)、大阪市立大学医学部附属病院(大阪府)、兵庫医科大学病院(兵庫県)、岡山大学病院(岡山県)、川崎市立多摩病院(神奈川県)、聖マリアンナ横浜市西部病院(神奈川県)、医療法人沖縄徳洲会湘南鎌倉病院(神奈川県)、聖路加国際病院(東京都)、杏林大学医学部付属病院(東京都)、東京慈恵会医科大学附属第三病院(東京都)、東京慈恵会医科大学附属柏病院(千葉県)、東京慈恵会医科大学葛飾医療センター(東京都)、富士市立中央病院(静岡県)、大崎市民病院(宮城県)、東京北社会保険病院(東京都)、公益財団法人地域医療振興教会練馬光が丘病院(東京都)、医療社団法人堀ノ内病院(埼玉県)、医療法人社団愛友会上尾中央病院(埼玉県)、東京女子医科大学病院(東京都)、愛知県厚生農業協同組合連合安城更生病院(愛知県)、市立四日市病院(三重県)、特定医療法人仁真会白鷺病院(大阪府)、社会医療法人景岳会南大阪病院(大阪府)、医療法人垣会明治橋病院(大阪府)、兵庫県立尼崎病院(兵庫県)、公立学校共済組合中国中央病院(広島県)、財団法人倉敷中央病院(岡山県)、南東北医療クリニック(福島県)、医療法人社団東光会戸田中央病院(埼玉県)、医療法人社団こうかん会こうかんクリニック(神奈川県)、藤沢市民病院(神奈川県)、愛媛県立中央病院(愛媛県)、JA愛知厚生連江南厚生病院(愛知県)、大阪大学医学部附属病院(大阪府)、島根大学医学部附属病院(島根県)、藤田保健衛生大学病院(愛知県)、横浜市立大学附属市民総合医療センター(神奈川県)、筑波大学附属病院(茨城県)、香川大学医学部附属病院(香川県)、山梨県立中央病院(山梨県)、足利赤十字病院(栃木県)、松山医院大分腎臓内科(大分県)、健康保険くまもと総合病院(熊本県)、NTT東日本関東病院(東京都)、医療法人社団弘健会菅原医院(東京都)


Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 04 Day


Related information

URL releasing protocol

http://www.trialsjournal.com/content/15/1/26

Publication of results

Published


Result

URL related to results and publications

https://www.ajkd.org/article/S0272-6386(18)30834-5/fulltext

Number of participants that the trial has enrolled

467

Results

Of 443 patients who were randomly assigned, 219 and 222 assigned to febuxostat and placebo, respectively, were included in the analysis. There was no significant difference in mean eGFR slope between the febuxostat and placebo groups (difference, 0.70; P=0.1).

Results date posted

2023 Year 11 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Enrolled were 467 patients with stage3 CKD and asymptomatic hyperuricemia at 55 medical institutions in Japan.

Participant flow

467 patients with stage3 CKD and asymptomatic hyperuricemia at 55 medical institutions in Japan. Participants were randomly assigned in a 1:1 ratio to receive febuxostat or placebo for 108 weeks. Of 443 patients who were randomly assigned, 219 and 222 assigned to febuxostat and placebo, respectively, were included in the analysis.

Adverse events

The incidence of gouty arthritis was significantly lower (P=0.007) in the febuxostat group (0.91%) than in the placebo group (5.86%). Adverse events specific to febuxostat were not observed.

Outcome measures

The primary end point was the slope(in mL/min/1.73 m2 per year) of estimated glomerular filtration rate (eGFR). Secondary end points included changes in eGFRs and serum uric acid levels at 24, 48, 72, and 108 weeks of follow-up and the event of doubling of serum creatinine level or initiation of dialysis therapy.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 06 Month 01 Day

Date of IRB

2012 Year 05 Month 31 Day

Anticipated trial start date

2012 Year 11 Month 07 Day

Last follow-up date

2016 Year 02 Month 29 Day

Date of closure to data entry

2016 Year 03 Month 30 Day

Date trial data considered complete

2016 Year 07 Month 27 Day

Date analysis concluded

2018 Year 04 Month 23 Day


Other

Other related information



Management information

Registered date

2012 Year 07 Month 04 Day

Last modified on

2023 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009817


Research Plan
Registered date File name

Research case data specifications
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Research case data
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