CompletedPhase 2

Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout

Japan60 participants

Plain-language 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.

Who can participate

Age range20 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Change from baseline in urine albumin creatinine ratio

Timeframe: 28 weeks

Trial details

NCT IDNCT02327754

SponsorSanwa Kagaku Kenkyusho Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Diabetic Nephropathy trials