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

Effect of Topiroxostat on Urinary Albumin Excretion in Patients With eARly Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout: a Randomized, Placebo-controlled, Double-blind Phase 2a Trial (UPWARD).

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 Overview

• Status: Completed
• Conditions: Diabetic Nephropathy
• Intervention / Treatment: Drug: Topiroxostat BID, (Oral daily dosing for 28 weeks); Drug: Placebo BID, (Oral daily dosing for 28 weeks)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 461-8631
      • Sanwa Kagaku Kenkyusho Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active comparator; Topiroxostat, (Oral daily dosing for 28 weeks)	Drug: Topiroxostat BID, (Oral daily dosing for 28 weeks); The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner.
Placebo Comparator: Placebo comparator; Placebo, (Oral daily dosing for 28 weeks)	Drug: Placebo BID, (Oral daily dosing for 28 weeks); Subjects randomized to the placebo arm will receive placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in urine albumin creatinine ratio	28 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC	28 weeks

Collaborators and Investigators

• Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
• Collaborators: Fuji Yakuhin Co., Ltd.

Study record dates

Study Major Dates

• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 24, 2014
• First Submitted That Met QC Criteria: December 24, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies; Hyperuricemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; FYX-051
• Other Study ID Numbers: FY1004