UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005573 |
|---|---|
| Receipt number | R000006596 |
| Scientific Title | The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia in chronic kidney disease. |
| Date of disclosure of the study information | 2011/05/16 |
| Last modified on | 2013/11/22 09:49:46 |
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Basic information
Public title
The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia in chronic kidney disease.
Acronym
The effects and safety of febuxostat in chronic kidney disease.
Scientific Title
The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia in chronic kidney disease.
Scientific Title:Acronym
The effects and safety of febuxostat in chronic kidney disease.
Region
| Japan |
Condition
Condition
Hyperuricemic patients with CKD
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia in chronic kidney disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Serum Uric acid
2) Serum Cr, eGFR
3) Derum systatin C
Key secondary outcomes
1) Urinary protein/Cr ratio
2) Urinary tubular markers/Cr ratio
3) Urinary uric acid excretion ratio
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)Febuxostat group
CKD patients with hyperuricemia (Uric acid more than 6mg/dl) are scheduled to treat with 10 mg/day of febuxostat in the beginnings. The doses of febxostat are allowed to increase until 40mg/day, if the serum levels of uric acid were not controlled to the target values.
Interventions/Control_2
2)Allopurinol group
CKD patients with hyperuricemia (Uric acid more than 6mg/dl) are scheduled to treat with 50mg/day of allopurinol in the beginnings. The dose of allopurinol is allowed to increase until 200mg/day, when the eGFR of the patients were equal or more than 50 ml/min/1.73m2. Similarly, the dose of allopurinol is allowed to increase until 100mg/day, when the eGFR of the patients were between 30 and 50 ml/min/1.73m2.
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)adult(older than 19 years-old)
2)regardless of gender
3)Uric acid equal and more than 8mg/dl and the eGFR of less than 60ml/min/1.73m2
4)The general condition of the participants need to be stable. The participants should be treated according to the CKD practice guideline except uric acid treatment
5) Written informed consent should be obtained by all participants.
Key exclusion criteria
1.The patients who are contraindicated
to use febuxostat or allopurinol.
1)Patients who have liver injury(The ALT more than 200 IU/L)
2) Woman who is pregnat.
3) Patients who have allergy to febuxostat or allopurinol.
2. Patients who are judged as
inadequate to participate the study by the their doctors.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhito Hirawa |
Organization
Yokohama City University Medical Center
Division name
Department of hemodialysis and apheresis
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhito Hirawa |
Organization
Yokohama City University Medical Center
Division name
Department of hemodialysis and apheresis
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
hirawa@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2013 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006596
