May. 20, 2022 |
|
Jan. 04, 2024 |
|
jRCTs031220080 |
Efficacy and safety of switching from febuxostat to dotinurad, a novel selective urate reabsorption inhibitor, in hyperuricemic patients with type 2 diabetes kidney disease (SWITCH SURI STUDY) |
|
Efficacy and safety of switching from febuxostat to dotinurad, a novel selective urate reabsorption inhibitor, in hyperuricemic patients with type 2 diabetes kidney disease (SWITCH SURI STUDY) |
Osonoi Takeshi |
||
Naka kinen Clinic |
||
745-5, Nakadai, Naka, Ibaraki, Japan |
||
+81-29-353-2800 |
||
t-osonoi@kensei-kai.com |
||
Katoh Makoto |
||
Naka kinen Clinic |
||
745-5, Nakadai, Naka, Ibaraki, Japan |
||
+81-29-353-2800 |
||
m-katou@kensei-kai.com |
Recruiting |
May. 20, 2022 |
||
50 | ||
Interventional |
||
single arm study |
||
open(masking not used) |
||
uncontrolled control |
||
single assignment |
||
treatment purpose |
||
Patients who meet all of the following criteria are included in this study; |
||
Patients who fall into any of the following criteria at the consent date are excluded from participating in the study. |
||
20age old over | ||
No limit | ||
Both |
||
diabetic kidney disease, Hyperuricemia |
||
The study subjects started oral administration of Uris Tablets 0.5 mg once daily within 1 week from the end of the baseline test. The uric acid level exceeded 6 mg/dL even after administration for 2 weeks or more, the dose of Uris tablets should be gradually increased (up to 4 mg) at the observation point or other regular visits. The observation period should be continued for up to 24 weeks. |
||
Hyperuricemia |
||
dotinurad, selective urate reabsorption inhibitor |
||
D033461, D003928 |
||
Proportion of patients who achieve serum uric acid level of 6 mg/dL or less at week 24 after Dotinurad administration |
||
The following items at observation points 4, 12, 24 weeks from baseline |
FUJI YAKUHIN CO., LTD | |
Not applicable |
MOCHIDA PHARMACEUTICAL CO., LTD. | |
Not applicable |
Clinical Research Review Board (CRRB) of Saitama Medical University | |
38,Morohongo,Moroyamamachi,Irumagun, Saitama | |
+81-49-276-1662 |
|
tokutei@saitama-med.ac.jp | |
Approval | |
No |
|
none |