Unique ID issued by UMIN | UMIN000007088 |
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Receipt number | R000008347 |
Scientific Title | The Novel XOI, Febuxostat: Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment |
Date of disclosure of the study information | 2012/01/17 |
Last modified on | 2014/07/17 09:17:30 |
The Novel XOI, Febuxostat: Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment
The NovEl XOI, FebuxostaT; Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment
(NEXT-STAR)
The Novel XOI, Febuxostat: Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment
The NovEl XOI, FebuxostaT; Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment
(NEXT-STAR)
Japan |
Hyperuricemia with moderate to severe renal impairment
Medicine in general | Endocrinology and Metabolism | Nephrology |
Others
NO
Evaluation of safety, torelability, and effect on serum uric acid and renal function of Febuxostat in hyperuricemia patients associated with moderate to severe renal impairment
Safety
Safety and Torelability:
Adverse event, number and incidence
Laboratory test
Vital sign, Blood Pressure
Serum uric acid value
Change rate of serum uric acid
Achievement rate of serum uric acid at 6.0mg/dL or less
Change rate of eGFR
Protein amount in urine
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Febuxostat is administered in dose escalation manner as follows, with careful check of safety and tolerability at each dose:
- Start 10 mg, once daily
- At 4 weeks after starting, dose up to 20 mg, once daily,
At 8 weeks after starting, dose up to 40 mg, once daily
Maximum dose is 60 mg once daily. If necessary, dose should be reduced to 40 mg after dosing up to 60 mg once daily.
20 | years-old | <= |
Not applicable |
Male and Female
Gout or hyperuricemia patients eligible for all the points of the following:
(1) Japanese male or female, 20 years old or above at the time of informed consent
(2) Serum uric acid > 8.0mg/dL
(3) eGFR< 45 mL/min./1.73 m2 Moderate (CKD stage 3b) to severe (CKD stage 4-5) renal impairment
(4) Not treated with uric acid lowering agent within 1 month before the timing of eligibility judgement
(5) Patinets from which informed consent is obtained
*: eGFR is calculated based on Japanese GFR formula
eGFR (mL/min/1.73 m2) = 194 x Serum creatinine(-1.094) x Age(-0.287) x 0.739 (if female)
(1)Patients having gouty attach at the time of eligibility judgment, or within 2 weeks after being cured from gout attack.
(2)Hepatic impairment patients (AST, ALT is more than double of standard values)
(3)Patients with unstable renal impairment, (50 % of change in sCR within 3 months), acute renal diseases or dialysis
(4)Patients having plan to receive dialysis or renal transplantaion during study
(5)Patinets having malignancy or other severe diseases
(6)Patients with hypersensitivity to febuxostat
(7)Pregnant female, lactation femal, hoping gestation
(8)Treated patients with mercaptopurine or azathioprine
(9)Patients whom study physicians consider as not eligible.
50
1st name | |
Middle name | |
Last name | Iwao Ohno1),Yugo Shibagaki2) |
1) Jikei University School of Medicine,
2) St Marianna University
1)Division of Kidney and Hypertension, 2)Division of Nephrology and Hypertension
1)3-25-8 Nishi-Shinbashi Minato-ku Tokyo, 2)2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
03-3433-1111
i-ohno@jikei.ac.jp
1st name | |
Middle name | |
Last name | Iwao Ohno1),Yugo Shibagaki2) |
1) Jikei University School of Medicine, 2) St Marianna University
1)Division of Kidney and Hypertension, 2)Division of Nephrology and Hypertension
1)3-25-8 Nishi-Shinbashi Minato-ku Tokyo,2) 2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
03-3433-1111
i-ohno@jikei.ac.jp
1) Jikei University School of Medicine, 2) St Marianna University
None
Self funding
None
None
NO
2012 | Year | 01 | Month | 17 | Day |
Published
Completed
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 01 | Month | 17 | Day |
2014 | Year | 07 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008347
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