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

Sanwa Kagaku Kenkyusho Co., Ltd.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetic Nephropathy

Interventions

Topiroxostat BID, (Oral daily dosing for 28 weeks)DRUG

The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner.

Placebo BID, (Oral daily dosing for 28 weeks)DRUG

Subjects randomized to the placebo arm will receive placebo.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Sanwa Kagaku Kenkyusho Co., Ltd.

Nagoya, Aichi-ken, Japan

Outcomes

Primary Outcomes

Change from baseline in urine albumin creatinine ratio

Time frame: 28 weeks

Secondary Outcomes

sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC

Time frame: 28 weeks

Data from ClinicalTrials.gov

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