Evidence mapPaperPMID 40839334Full record

Trial reportClinical and experimental nephrology2025

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

Toshinari Takahashi, Takanobu Beppu, Tatsuo Hosoya, Naoto Yokota

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical and experimental nephrology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03006445 (Official Title), which is not on this map. Not yet cited in PubMed.

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0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03006445 phase3completednot on this map

Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)

TypeinterventionalSponsorFuji Yakuhin Co., Ltd.Ran2016 to 2018Enrolled330ConditionsHyperuricemia With or Without GoutArmsFYU-981
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Toshinari TakahashiMedical Affairs Department, Mochida Pharmaceutical Co., Ltd, 7 Yotsuya 1-chome, Shinjuku-ku, Tokyo, 160-8515, Japan.ORCID http://orcid.org/0000-0002-2925-9732
Takanobu BeppuMedical Affairs Department, Fuji Yakuhin Co., Ltd, 9 F Kanda Square Building, 2-2-1 Kandanishiki-cho, Chiyoda City, Tokyo, 101-8189, Japan. beppu@fujiyakuhin.co.jp.
Tatsuo HosoyaJikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato City, Tokyo, 105-8461, Japan.
Naoto YokotaYokota Naika, 642-1 Komuta Hanagashimacho, Miyazaki City, Miyazaki, 880-0036, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlbuminuria 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.

methodsThe 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.

resultsData 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.

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

Indexed as

AlbuminuriaHyperuricemiaAdministration, OralAdultAgedBenzothiazolesBiomarkersCreatinineHumansJapanMaleMiddle AgedTime FactorsTreatment OutcomeBenzothiazolesBiomarkersCreatininedotinuradAlbuminuriaDotinuradSelective urate reabsorption inhibitorSURIURAT1Urate transporter 1

Identifiers

PMID40839334
PMCPMC12464093

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.