Diabetic Nephropathy
Conditions
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.
Interventions
DRUGTopiroxostat BID, (Oral daily dosing for 28 weeks)
The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner.
DRUGPlacebo BID, (Oral daily dosing for 28 weeks)
Subjects randomized to the placebo arm will receive placebo.
Sponsors
Fuji Yakuhin Co., Ltd.
Sanwa Kagaku Kenkyusho Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in urine albumin creatinine ratio | 28 weeks |
Secondary
| Measure | Time frame |
|---|---|
| sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC | 28 weeks |
Countries
Japan
Outcome results
None listed