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Background <p>Albuminuria is an important indicator of kidney damage. It increases the risk of adverse outcomes such as end-stage renal failure and cardiovascular events. Dotinurad, a drug newly developed in Japan, selectively inhibits renal urate transporter 1. This post hoc analysis of a Japanese, multicenter, phase 3 clinical trial (ClinicalTrials.gov identifier, NCT03006445) of dotinurad in patients with hyperuricemia investigated the effects on urinary albumin levels among a subset of patients with microalbuminuria.</p> Methods <p>The study endpoint was the change in urine albumin-to-creatinine ratio (UACR) from baseline at Weeks 34 and 58. Subgroup analyses by patient background and clinical characteristics assessed potential correlations with the change in UACR.</p> Results <p>Data from 39 patients were analyzed. All were male (mean age, 57.5&#xa0;years). At Week 34, the geometric mean of the change in UACR was −43.5% (95% confidence interval [CI] −55.3%, −28.6%; linear mixed effects model, p &lt; 0.05). At Week 58, the geometric mean of the change was −41.5% (95% CI −73.5%, 29.1%; linear mixed effects model, p &lt; 0.05). There were no significant correlations between the rate of change in UACR and background characteristics such as body mass index or complicating diabetes. Systolic blood pressure level was significantly correlated with the rate of change in UACR at Week 34.</p> Conclusion <p>A significant decrease in UACR following dotinurad administration was observed. Additional RCTs with appropriate control groups are needed to further confirm these findings.</p>

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Changes in urinary albumin levels with dotinurad oral administration in hyperuricemic patients with microalbuminuria: a post hoc analysis

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  • 发表日期：

    2025年8月21日

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  • Toshinari Takahashi,
  • Takanobu Beppu,
  • Tatsuo Hosoya,
  • Naoto Yokota

摘要

Background

Albuminuria is an important indicator of kidney damage. It increases the risk of adverse outcomes such as end-stage renal failure and cardiovascular events. Dotinurad, a drug newly developed in Japan, selectively inhibits renal urate transporter 1. This post hoc analysis of a Japanese, multicenter, phase 3 clinical trial (ClinicalTrials.gov identifier, NCT03006445) of dotinurad in patients with hyperuricemia investigated the effects on urinary albumin levels among a subset of patients with microalbuminuria.

Methods

The study endpoint was the change in urine albumin-to-creatinine ratio (UACR) from baseline at Weeks 34 and 58. Subgroup analyses by patient background and clinical characteristics assessed potential correlations with the change in UACR.

Results

Data from 39 patients were analyzed. All were male (mean age, 57.5 years). At Week 34, the geometric mean of the change in UACR was −43.5% (95% confidence interval [CI] −55.3%, −28.6%; linear mixed effects model, p < 0.05). At Week 58, the geometric mean of the change was −41.5% (95% CI −73.5%, 29.1%; linear mixed effects model, p < 0.05). There were no significant correlations between the rate of change in UACR and background characteristics such as body mass index or complicating diabetes. Systolic blood pressure level was significantly correlated with the rate of change in UACR at Week 34.

Conclusion

A significant decrease in UACR following dotinurad administration was observed. Additional RCTs with appropriate control groups are needed to further confirm these findings.