drugset / Trial / NCT03006445
Study of FYU-981 in Hyperuricemia With or Without Gout
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.
Timeline
- Start
- 2016-12
- Primary completion
- 2018-08-23
- Completion
- 2018-10-24
Publications
- Takahashi T, Beppu T, Hosoya T, Yokota N. Changes in urinary albumin levels with dotinurad oral administration in hyperuricemic patients with microalbuminuria: a post hoc analysis. Clin Exp Nephrol. 2025 Oct;29(10):1384-1393. doi: 10.1007/s10157-025-02750-4. Epub 2025 Aug 21.
- Hosoya T, Fushimi M, Okui D, Sasaki T, Ohashi T. Open-label study of long-term administration of dotinurad in Japanese hyperuricemic patients with or without gout. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):80-91. doi: 10.1007/s10157-019-01831-5. Epub 2019 Dec 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dotinurad | Small molecule | 2 mg | Oral |
| Subject | Dotinurad | Small molecule | 4 mg | Oral |