NCT02327754

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 12, 2017

Status Verified

November 1, 2015

First QC Date

December 24, 2014

Last Update Submit

April 10, 2017

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in urine albumin creatinine ratio

    28 weeks

Secondary Outcomes (1)

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

    28 weeks

Study Arms (2)

Active comparator

ACTIVE COMPARATOR

Topiroxostat, (Oral daily dosing for 28 weeks)

Drug: Topiroxostat BID, (Oral daily dosing for 28 weeks)

Placebo comparator

PLACEBO COMPARATOR

Placebo, (Oral daily dosing for 28 weeks)

Drug: Placebo BID, (Oral daily dosing for 28 weeks)

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.

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

Subjects randomized to the placebo arm will receive placebo.

Placebo comparator

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient has known non-diabetic nephropathy (other than nephrosclerosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanwa Kagaku Kenkyusho Co., Ltd.

Nagoya, Aichi-ken, 461-8631, Japan

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2014

First Posted

December 30, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 12, 2017

Record last verified: 2015-11

Locations

JP(1)