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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005964
Receipt No. R000007048
Scientific Title Influence of febuxostat and allopurinol on renal function for hyperuricemia
Date of disclosure of the study information 2011/07/11
Last modified on 2012/12/27

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Basic information
Public title Influence of febuxostat and allopurinol on renal function for hyperuricemia
Acronym Influence of afebuxostat and allopurinol on renal function for hyperuricemia
Scientific Title Influence of febuxostat and allopurinol on renal function for hyperuricemia
Scientific Title:Acronym Influence of afebuxostat and allopurinol on renal function for hyperuricemia
Region
Japan

Condition
Condition Hyperuricemic patients (Uric acid>8.0mg/dL)
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of present study is to evaluate the urate-lowering efficacy and renal function of febuxostat and allopurinoln.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Serum uric acid
2) Urinary Albumin
Key secondary outcomes 1) serum Cr
2) eGFR
3) cystatin C
4) Oxidized LDL
5) T-cho, TG, LDL,HDL
6)PWV
7)BNP, EF, LVM
8) side effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Febuxostat group: The patients was treated by 10 mg/day of febuxostat and controlled Uric acid less than 6mg/dl/ (maximum 60 mg/day of febuxostat)
Interventions/Control_2 Allopurinol group: The patients was treated by 100 mg/day of allopurinol and controlled Uric acid less than 6mg/dl/ (maximum 300 mg/day of febuxostat)
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Serum Uric acid>8.0mg/dl
Patients from whom informed consent was obtained
Key exclusion criteria The patients who are contraindicated to use febuxostat or allopurinol.
Patients who do not agree and whom physician judges inappropriate to this trial for any reason
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Sezai
Organization Nihon University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nihon University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
Email asezai.med@gmail.com

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sekino Hospital
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 日本大学医学部附属板橋病院(東京都)、関野病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 11 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 Completed
Date of protocol fixation
2011 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 11 Day
Last modified on
2012 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007048

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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