Mizukoshi T, et al. - This study entails an assessment of the anti-albuminuric impacts of topiroxostat in Japanese hyperuricemic patients with diabetic nephropathy. Findings demonstrated that daily treatment with topiroxostat 160 mg attenuated albuminuria in this patient population.

Methods

• This 24-week, multicenter, open-label, randomized (1:1) trial included hyperuricemic patients with diabetic nephropathy (estimated glomerular filtration rate ≥ 20 mL/min/1.73m²) and overt proteinuria (0.3 ≤ urine protein to creatinine ratio (UPCR) <3.5 g/g Cr) who were randomized to either high dose (160 mg daily) or low dose (40 mg daily) topiroxostat.
• Change in albuminuria indicated by urine albumin-to-creatinine ratio (UACR) from the baseline at the final time point was the primary endpoint

Results

• In this study, randomization of a total of 80 patients was done.
• Researchers found that compared to the baseline, changes in UACR after 24 weeks of treatment (or at the final time point if patients failed to reach 24 weeks) were -122 mg/gCr (95% CI: -5.1 to -240.1, P = 0.041) in patients treated with high dose, while no significant reduction was evident in those treated with low dose topiroxostat (P = 0.067).
• In addition, it was evident in the linear mixed model including baseline albuminuria, eGFR, age, and sex as covariates that in the high dose group, the decreases in UACR were still significant from baseline to 12 weeks by 228.7 ± 83.2 mg/gCr (P = 0.0075).
• During this study, no difference was reported in terms of adverse-event profile between the groups.