Evidence map›Paper›PMID 41121263›Full record

ArticleJournal of pharmaceutical health care and sciences2025

Renal maturation and catch-up clearance of ganciclovir in a preterm neonate: Bayesian pharmacokinetic analysis using a population model.

Katsuya Kata, Satomi Inomata, Mitsuru Nishikawa, Haruka Ide, Kentaro Nakamura, Taketoshi Yoshida, Masato Taguchi

Abstract read
In one paragraph

Article in Journal of pharmaceutical health care and sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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0cells of the map it votes in
1citing papers in PubMed
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1 · What the graph read from it

What it found

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2 · The registry

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Katsuya KataDepartment of Pharmacy Practice and Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan.
Satomi InomataDivision of Neonatology, Maternal and Perinatal Center, Toyama University Hospital, Toyama, Japan.
Mitsuru NishikawaDepartment of Pharmacy Practice and Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan.
Haruka IdeDepartment of Pharmacy Practice and Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan.
Kentaro NakamuraDivision of Neonatology, Maternal and Perinatal Center, Toyama University Hospital, Toyama, Japan.
Taketoshi YoshidaDivision of Neonatology, Maternal and Perinatal Center, Toyama University Hospital, Toyama, Japan.
Masato TaguchiDepartment of Pharmacy Practice and Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan. taguchi@pha.u-toyama.ac.jp.

Funding

JST SPRING JPMJSP2145the Japanese Society for the Promotion of Sciences (JSPS KAKENHI) 24K09911
6 · The paper itself

Abstract

backgroundCongenital cytomegalovirus (CMV) infection is a major cause of neonatal morbidity. However, optimizing ganciclovir (GCV) dosing in preterm infants is complicated by immature renal function and developmental pharmacokinetics. Population pharmacokinetic (PPK) parameters for GCV and valganciclovir (VGCV) have been reported, but data remain limited for extremely low birth weight infants. We aimed to characterize longitudinal changes in GCV clearance in a preterm infant with congenital CMV infection using Bayesian modeling.

methodsGCV/VGCV were administered over a 15-week period, with concurrent therapeutic drug monitoring. Individual parameters were estimated using a previously published PPK model and a postnatal age-based maturation function in NONMEM. Scr clearance was measured at two time points using the 24-h urine collection method.

resultsGCV clearance increased from 0.048 to 0.273 L/hr/kg from postnatal day 30 to day 93, whereas VGCV bioavailability remained stable (~ 52-55%). Scr clearance values matched estimated GCV clearance, supporting the validity of the model. The maturation function indicated that tubular secretion likely contributes to accelerated drug elimination. Late-phase GCV clearance exceeded typical glomerular filtration rate, indicating possible catch-up in renal function.

conclusionRenal maturation should be considered in addition to body weight when adjusting GCV dosing in preterm infants. This case highlights the importance of aligning individualized dosing strategies with the developmental physiology of preterm neonates.

Indexed as

DevelopmentalGanciclovirInfantsLow birth weightMaturationPPKPretermValganciclovir

Identifiers

PMID41121263
PMCPMC12538932

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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 OpenQuestion graph.