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
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
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
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
