MedTrace Logo

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

NCT02327754 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-04-12

No results posted yet for this study

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

  • Diabetic Nephropathy

Interventions

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.

Sponsors & Collaborators

  • Fuji Yakuhin Co., Ltd.

    collaborator INDUSTRY

  • Sanwa Kagaku Kenkyusho Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02327754 on ClinicalTrials.gov