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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000008343
Receipt No. 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 2018/10/12

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
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
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
Middle name
Last name Yoji Mitadera
Organization Public Health Research Foundation (PHRF)
Division name Comprehensive Support Project for Clinical Research of Lifestyle-Related Disease (CSP-LD)
Zip code
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
Institute Public Health Research Foundation (PHRF)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Address
Tel
Email

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
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 Main results already published
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
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
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009817


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