This trial is active, not recruiting.

Condition diabetic nephropathy
Treatments topiroxostat bid, (oral daily dosing for 28 weeks), placebo bid, (oral daily dosing for 28 weeks)
Phase phase 2
Sponsor Sanwa Kagaku Kenkyusho Co., Ltd.
Collaborator Fuji Yakuhin Co., Ltd.
End date December 2016
Trial size 60 participants
Trial identifier NCT02327754, FY1004


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Topiroxostat, (Oral daily dosing for 28 weeks)
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, (Oral daily dosing for 28 weeks)
placebo bid, (oral daily dosing for 28 weeks)
Subjects randomized to the placebo arm will receive placebo.

Primary Outcomes

Change from baseline in urine albumin creatinine ratio
time frame: 28 weeks

Secondary Outcomes

time frame: 28 weeks

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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)

Additional Information

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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Sanwa Kagaku Kenkyusho Co., Ltd..