Evidence map›Paper›PMID 42631820›Full record

ArticleClinical pharmacokinetics2026

Pharmacokinetics, Elimination and Dialyzability of HRS-9231 in Patients with Varying Degrees of Renal Impairment.

Qiwen Han, Rongjun Zhang, Yan He, Rui Yan, Litong Shi, Nan Wu, Luhai Yu, Gulimire Muhetaer, Xiangyun Meng, Li Liu and 3 more

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06657560 (Pharmacokinetics), which is not on this map. Not yet cited in PubMed.

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

NCT06657560 phase1completednot on this map

Pharmacokinetics (PK) Study of HRS-9231 Injection in Chinese Subjects With Renal Impairment and Normal Renal Function

TypeinterventionalSponsorShanghai Shengdi Pharmaceutical Co., LtdRan2024 to 2025Enrolled41ConditionsContrast-Enhanced Magnetic Resonance Imaging DetectionArmsHRS-9231
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

13 authors.

Qiwen Han *Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.ORCID http://orcid.org/0000-0002-9213-5417
Rongjun Zhang *Clinical Trial Center, Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development, Jinan, China.
Yan HePhase I Clinical Trial Laboratory, Guizhou Medical University Affiliated Hospital, Guiyang, China.
Rui YanNephrology Department, Guizhou Medical University Affiliated Hospital, Guiyang, China.
Litong ShiPhase I Clinical Trial Laboratory, China-Japan Union Hospital of Jilin University, Changchun, China.
Nan WuPhase I Clinical Trial Laboratory, China-Japan Union Hospital of Jilin University, Changchun, China.
Luhai YuDepartment of Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.
Gulimire MuhetaerDepartment of Nephrology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.
Xiangyun MengPhase I Clinical Trial Laboratory, The Second People's Hospital of Hefei, Hefei, China.
Li LiuDepartment of Nephrology, The Second People's Hospital of Hefei, Hefei, China.
Tengrui YinJiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Yuanyuan HuangJiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Wei ZhaoClinical Trial Center, Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development, Jinan, China. zhao4wei2@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis study aimed to characterize the pharmacokinetics (PK), elimination and dialysability of HRS‑9231, a novel macrocyclic gadolinium‑based contrast agent, in individuals with varying degrees of renal impairment, including those requiring hemodialysis.

methodsIn this open‑label, non‑randomized, Phase 1 study, 40 participants were stratified into five cohorts based on renal function: normal, mild, moderate, severe impairment, and end‑stage renal disease (ESRD). All received a single intravenous dose of HRS‑9231 (0.05 mmol/kg). Intensive PK sampling was performed over 96-120 h. End‑stage renal disease patients underwent hemodialysis sessions post‑dose, with concurrent plasma and dialysate collection. Long‑term gadolinium elimination and safety were monitored for up to 6 months.

resultsSystemic exposure to HRS‑9231 increased with renal impairment severity: geometric mean area under the plasma concentration versus time curve from zero to infinity (AUC

conclusionsHRS‑9231 exhibits a PK profile consistent with renal elimination. Its clearance decreases proportionally with renal impairment, and it is effectively cleared by hemodialysis. HRS‑9231 was generally well tolerated in this small cohort of patients with varying degrees of renal impairment, including those on hemodialysis. No new safety signals or NSF cases were identified. These findings, together with the PK data, support that dose adjustment is unlikely to be necessary for patients with any degree of renal impairment.

trial registrationClinicalTrials.gov Identifier: NCT06657560.

Indexed as

Contrast MediaGadoliniumKidney Failure, ChronicRenal InsufficiencyAdultAgedArea Under CurveFemaleHalf-LifeHumansMaleMiddle AgedRenal DialysisContrast MediaGadolinium

Identifiers

PMID42631820

What Socratic holds

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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 Socratic graph.