Trials / Completed
CompletedNCT02327754
Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout
Effect of Topiroxostat on Urinary Albumin Excretion in Patients With eARly Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout: a Randomized, Placebo-controlled, Double-blind Phase 2a Trial (UPWARD).
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the effect of topiroxostat on urinary albumin excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40) for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO., LTD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Topiroxostat BID, (Oral daily dosing for 28 weeks) | The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner. |
| DRUG | Placebo BID, (Oral daily dosing for 28 weeks) | Subjects randomized to the placebo arm will receive placebo. |
Timeline
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2014-12-30
- Last updated
- 2017-04-12
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02327754. Inclusion in this directory is not an endorsement.