Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout
Phase 2
Completed
- Conditions
- Diabetic Nephropathy
- Interventions
- Drug: Placebo BID, (Oral daily dosing for 28 weeks)
- Registration Number
- NCT02327754
- Lead Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Diabetes patients
- Clinically or pathologically diagnosed diabetic nephropathy
- Hyperuricemic or gout patients
- Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73m^2 and urine albumin creatinine ratio (UACR) greater than or equal to 45 and less than 300 mg/g
Exclusion Criteria
- Patient has known non-diabetic nephropathy (other than nephrosclerosis)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo comparator Placebo BID, (Oral daily dosing for 28 weeks) Placebo, (Oral daily dosing for 28 weeks) Active comparator Topiroxostat BID, (Oral daily dosing for 28 weeks) Topiroxostat, (Oral daily dosing for 28 weeks)
- Primary Outcome Measures
Name Time Method Change from baseline in urine albumin creatinine ratio 28 weeks
- Secondary Outcome Measures
Name Time Method sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC 28 weeks
Trial Locations
- Locations (1)
Sanwa Kagaku Kenkyusho Co., Ltd.
馃嚡馃嚨Nagoya, Aichi, Japan