Evidence map›Paper›PMID 42059789›Full record

ArticleAntimicrobial agents and chemotherapy2026

A multi-center, open-label, two-part study to investigate the effect of renal function and hemodialysis on the pharmacokinetics of the novel β-lactamase inhibitor nacubactam.

Jun Morita, Kazuya Ishiwata, Shogo Matsumoto, Ignacio Rodriguez, Katie Patel, Gemma Attley, Navita L Mallalieu, Darren Bentley

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

8 authors.

Jun MoritaMeiji Seika Pharma Co. Ltd., Tokyo, Japan.ORCID 0000-0002-8242-0812
Kazuya IshiwataMeiji Seika Pharma Co. Ltd., Tokyo, Japan.
Shogo MatsumotoMeiji Seika Pharma Co. Ltd., Tokyo, Japan.
Ignacio RodriguezRoche Pharma Research and Early Development, Roche Innovation Centre New York, Little Falls, New Jersey, USA.
Katie PatelGlobal Product Development, Roche Products Limited, Welwyn Garden City, United Kingdom.
Gemma AttleyRoche Pharma Research and Early Development, Roche Innovation Centre New York, New York, New York, USA.
Navita L MallalieuRoche Pharma Research and Early Development, Roche Innovation Centre New York, New York, New York, USA.ORCID 0000-0002-7203-6307
Darren BentleyCertara Drug Development Solutions, Certara, Sheffield, United Kingdom.

Funding

Administration for Strategic Preparedness and Response HHSO100201600038CBiomedical Advanced Research and Development Authority HHSO100201600038CF. Hoffmann-La Roche HHSO100201600038C
6 · The paper itself

Abstract

Nacubactam is a novel bicyclic non-β-lactam β-lactamase inhibitor that acts as a penicillin-binding protein (PBP-2) active antibacterial, almost exclusively cleared by renal excretion. This study assessed the effect of renal function and hemodialysis on nacubactam pharmacokinetics following a single intravenous (IV) 1 g infusion. Part 1 included three subjects with normal renal function, and six each with mild, moderate, or severe renal impairment; Part 2 included eight subjects with end-stage renal disease undergoing hemodialysis. We observed a strong linear relationship between renal function and both nacubactam total clearance and renal clearance. Compared with subjects with normal renal function, mean nacubactam total clearance was 49%, 73%, and 85% lower among subjects with mild, moderate, and severe renal impairment, respectively, and renal clearance was 42%, 70%, and 90% lower. Nacubactam systemic exposure was correspondingly greater in subjects with impaired renal function. Compared with the normal renal function group, AUC

Indexed as

Anti-Bacterial AgentsAzabicyclo Compoundsbeta-Lactamase InhibitorsLactamsRenal DialysisAgedFemaleHumansKidneyKidney Failure, ChronicMaleMiddle AgedAnti-Bacterial AgentsAzabicyclo Compoundsbeta-Lactamase InhibitorsLactamsnacubactamESRDnacubactampharmacokineticsrenal impairmentβ-lactamase inhibitor

Identifiers

PMID42059789
PMCPMC13231898

What OpenQuestion holds

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Registered trials

None linked

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.