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 |
The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia in chronic kidney disease.
The effects and safety of febuxostat in chronic kidney disease.
The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia in chronic kidney disease.
The effects and safety of febuxostat in chronic kidney disease.
Japan |
Hyperuricemic patients with CKD
Nephrology |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
1) Serum Uric acid
2) Serum Cr, eGFR
3) Derum systatin C
1) Urinary protein/Cr ratio
2) Urinary tubular markers/Cr ratio
3) Urinary uric acid excretion ratio
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
40
1st name | |
Middle name | |
Last name | Nobuhito Hirawa |
Yokohama City University Medical Center
Department of hemodialysis and apheresis
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
1st name | |
Middle name | |
Last name | Nobuhito Hirawa |
Yokohama City University Medical Center
Department of hemodialysis and apheresis
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
hirawa@yokohama-cu.ac.jp
Yokohama City University Medical Center
None
Self funding
NO
横浜市立大学附属市民総合医療センター(神奈川県)
2011 | Year | 05 | Month | 16 | Day |
Published
Completed
2011 | Year | 03 | Month | 24 | Day |
2011 | Year | 05 | Month | 01 | Day |
2016 | Year | 04 | Month | 01 | Day |
2011 | Year | 05 | Month | 09 | Day |
2013 | Year | 11 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006596