Evidence map›Paper›PMID 31823130›Full record

Trial reportClinical and experimental nephrology2020

Effects of mild and moderate renal dysfunction on pharmacokinetics, pharmacodynamics, and safety of dotinurad: a novel selective urate reabsorption inhibitor.

Hiroyuki Fukase, Daisuke Okui, Tomomitsu Sasaki, Masahiko Fushimi, Tetsuo Ohashi, Tatsuo Hosoya

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Clinical and experimental nephrology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02347046 (Clinical Pharmacology Study of FYU-981 for Subjects With Renal Insufficiency.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02347046 phase1completednot on this map

Clinical Pharmacology Study of FYU-981 for Subjects With Renal Insufficiency.

TypeinterventionalSponsorFuji Yakuhin Co., Ltd.Ran2015 to 2015Enrolled18ConditionsRenal Insufficiency, HealthyArmsFYU-981, (Oral single dosing)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
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

6 authors.

Hiroyuki FukaseClinical Research Hospital Tokyo, NT-Building Level 3, 3-87-4, Hara-machi, Shinjuku-ku, Tokyo, 162-0053, Japan.
Daisuke OkuiMedical R&D Division, Development Department, Fuji Yakuhin Co., Ltd., 4-383, Sakuragi-cho, Omiya-ku, Saitama-shi, Saitama, 330-9508, Japan. d-okui@fujiyakuhin.co.jp.
Tomomitsu SasakiMedical R&D Division, Development Department, Fuji Yakuhin Co., Ltd., 4-383, Sakuragi-cho, Omiya-ku, Saitama-shi, Saitama, 330-9508, Japan.
Masahiko FushimiMedical R&D Division, Development Department, Fuji Yakuhin Co., Ltd., 4-383, Sakuragi-cho, Omiya-ku, Saitama-shi, Saitama, 330-9508, Japan.
Tetsuo OhashiMedical R&D Division, Development Department, Fuji Yakuhin Co., Ltd., 4-383, Sakuragi-cho, Omiya-ku, Saitama-shi, Saitama, 330-9508, Japan.
Tatsuo HosoyaJikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDotinurad, a novel selective urate reabsorption inhibitor, exerts a serum uric acid-lowering effect by selectively inhibiting urate transporter 1 (URAT1) in patients with hyperuricemia. It is generally known that the progression of renal dysfunction is associated with a reduction in the serum uric acid-lowering effects of uricosuric drugs. We, therefore, investigated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of dotinurad in subjects with renal dysfunction.

methodsThis was a parallel-group, open-label, single-dose clinical pharmacology study. Dotinurad (1 mg) was administered once, orally to subjects with mild (estimated glomerular filtration rate [eGFR], ≥ 60 to < 90 mL/min/1.73 m

resultsThe time-course of mean plasma concentration of dotinurad had similar profiles across the groups. Regarding PK, there was no significant difference between the renal dysfunction groups and normal renal function group. Regarding PD, the maximum reduction rate in serum uric acid levels and the fractional uric acid excretion (FE) ratio (FE

conclusionThese results suggested that no dose adjustment might be necessary when administering dotinurad to patients with mild-to-moderate renal dysfunction. ClinicalTrials.gov Identifier: NCT02347046.

Indexed as

Uricosuric AgentsAdultAgedBenzothiazolesGlomerular Filtration RateHumansMaleMiddle AgedRenal InsufficiencyUric AcidBenzothiazolesdotinuradUric AcidUricosuric AgentsDotinuradPharmacodynamicsPharmacokineticsRenal dysfunctionSelective urate reabsorption inhibitorURAT1 inhibitor

Identifiers

PMID31823130
PMCPMC7066277

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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 OpenQuestion graph.