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

Diabetic Nephropathy Clinical Trial

— UPWARD  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327754
• Other study ID #: FY1004
• Status: Completed
• Phase: Phase 2
• First received: December 24, 2014
• Last updated: April 10, 2017
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: Sanwa Kagaku Kenkyusho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Hyperuricemia
• Kidney Diseases

Intervention

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 BID, (Oral daily dosing for 28 weeks)
Subjects randomized to the placebo arm will receive placebo.

Locations

Country	Name	City	State
Japan	Sanwa Kagaku Kenkyusho Co., Ltd.	Nagoya	Aichi

Sponsors (2)

Lead Sponsor	Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.	Fuji Yakuhin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in urine albumin creatinine ratio		28 weeks
Secondary	sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC		28 weeks