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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active comparator

Topiroxostat, (Oral daily dosing for 28 weeks)

Group Type ACTIVE_COMPARATOR

Topiroxostat BID, (Oral daily dosing for 28 weeks)

Intervention Type DRUG

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

Placebo comparator

Placebo, (Oral daily dosing for 28 weeks)

Group Type PLACEBO_COMPARATOR

Placebo BID, (Oral daily dosing for 28 weeks)

Intervention Type DRUG

Subjects randomized to the placebo arm will receive placebo.

Interventions

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Topiroxostat BID, (Oral daily dosing for 28 weeks)

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

Intervention Type DRUG

Placebo BID, (Oral daily dosing for 28 weeks)

Subjects randomized to the placebo arm will receive placebo.

Intervention Type DRUG

Eligibility Criteria

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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