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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008727
Receipt No. R000010227
Scientific Title Effect of febuxostat on serum uric acid and renal function in patients with hyperuricemia. -open label, active (allopurinol)-controlled clinical study-
Date of disclosure of the study information 2012/09/01
Last modified on 2019/08/26

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Basic information
Public title Effect of febuxostat on serum uric acid and renal function in patients with hyperuricemia. -open label, active (allopurinol)-controlled clinical study-
Acronym Effect of febuxostat on serum uric acid and renal function
Scientific Title Effect of febuxostat on serum uric acid and renal function in patients with hyperuricemia. -open label, active (allopurinol)-controlled clinical study-
Scientific Title:Acronym Effect of febuxostat on serum uric acid and renal function
Region
Japan

Condition
Condition Hyperuricemia
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the effect of febuxostat on serum uric acid and estimated GFR in patients treated with allopurinol, and compare them between allopurinol and febuxostat.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes change ratio of serum uric acid
eGFR change from baseline
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Allopurino50-100mg
Interventions/Control_2 Febuxostat10-20mg
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)Patients with hyperuricemia and renal dysfunction
(2)Patients who treated with allopurinol, and their levels of serum uric acid are more than 6.0mg/dl
(3)eGFR<60ml/min/1.73m2
Key exclusion criteria (1)Febuxostat sensitivity
(2)Hemodialysis patients
(3)Secondary hyperuricemia
(4)SBP>=160 or DBP>=100
(5)AST and ALT levels less than 2-times the upper limit of normal
(6)Newly onset CAD and CVD within 6 months
(7)Treated with mercaptopurine and azathioprine
(8)During breast-feeding
(9)Doctor considers inappropriate as subjects
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohito Gohda
Organization Juntendo University Faculty of Medicine
Division name Division of Nephrology, Department of Internal Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University Faculty of Medicine
Division name Division of Nephrology, Department of Internal Medicine
Zip code
Address
TEL 03-5802-1065
Homepage URL
Email

Sponsor
Institute Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 07 Month 27 Day
Date of IRB
2012 Year 07 Month 27 Day
Anticipated trial start date
2012 Year 07 Month 28 Day
Last follow-up date
2013 Year 07 Month 31 Day
Date of closure to data entry
2013 Year 07 Month 31 Day
Date trial data considered complete
2013 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 20 Day
Last modified on
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010227

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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