Unique ID issued by UMIN | UMIN000016172 |
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Receipt number | R000016736 |
Scientific Title | Multicenter Investigation of Xanthine Oxidase Inhibitor Efficacy for CKD patients with Hyperuricemia |
Date of disclosure of the study information | 2015/01/12 |
Last modified on | 2020/01/20 12:28:29 |
Multicenter Investigation of Xanthine Oxidase Inhibitor Efficacy for CKD patients with Hyperuricemia
MIE-CKD study
Multicenter Investigation of Xanthine Oxidase Inhibitor Efficacy for CKD patients with Hyperuricemia
MIE-CKD study
Japan |
chronic kidney disease
Nephrology |
Others
NO
To evaluate the urine protein decrease efficacy of the xanthine oxidase inhibitor on the chronic kidney disease patient with hyperuricemia.
Efficacy
Exploratory
urine protein
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine |
topiroxostat
febuxostat
20 | years-old | <= |
80 | years-old | > |
Male and Female
serum uric acid ;7.0mg/dl
eGFR 15-60ml/min
urine protein creatinine ratio 0.15-3.5g/gCr
gout attack within 4 weeks
obstructive uropathy
primary hyperuricemia
use xanthine oxidase inhibitor within 4 weeks
malignant disease
100
1st name | Masaaki |
Middle name | |
Last name | Ito |
Mie University Hospital
Cardiology and Nephrology
514-8507
174, Edobashi-2, Tsu, Mie, Japan
059-232-1111
doumon1@clin.medic.mie-u.ac.jp
1st name | Hiroshi |
Middle name | |
Last name | Matsuo |
Suzuka Kaisei Hospital
Nephrology and Dialysis
513-0836
112, Koh-chou, Suzuka, Mie, Japan
059-375-1212
hmatsuo.16@gmail.com
Mie University Hospital
SANWA KAGAKU KENKYUSHO CO.,LTD.
Profit organization
Mie University Hospital
174, Edobashi-2, Tsu, Mie, Japan
059-232-1111
doumon1@clin.medic.mie-u.ac.jp
NO
2015 | Year | 01 | Month | 12 | Day |
https://link.springer.com/article/10.1007%2Fs10157-019-01829-z
Published
https://link.springer.com/article/10.1007%2Fs10157-019-01829-z
101
The change in the median uPCR were not significant. The sUA levels decreased significantly in both groups. No significant change in the eGFR was noted in either the Topiroxostat or Febuxostat group.
2020 | Year | 01 | Month | 20 | Day |
CKD patients with hyperuricemia
A total of 101 patients were initially enrolled, and 7 were excluded from the data analysis after enrollment because 5 did not meet inclusion criteria and 2 met the exclusion criteria. 46 patients were assigned to the Topiroxostat group and 48 to the Febuxostat group for the analysis.
No severe adverse events caused by XO inhibitors were observed in our study.
The primary outcome was the change in the uPCR in the 2 groups between baseline and 24 weeks. The secondary outcomes were the changes in the eGFR, sUA levels, systolic and diastolic blood pressure (SBP and DBP, respectively), and urinary liver-type fatty acid binding protein (L-FABP) between baseline and 24 weeks.
Main results already published
2014 | Year | 06 | Month | 14 | Day |
2014 | Year | 10 | Month | 03 | Day |
2015 | Year | 01 | Month | 12 | Day |
2018 | Year | 01 | Month | 31 | Day |
2015 | Year | 01 | Month | 09 | Day |
2020 | Year | 01 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016736
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