Trial reportClinical pharmacokinetics2009
Population pharmacokinetics of ganciclovir following administration of valganciclovir in paediatric renal transplant patients.
Trial report in Clinical pharmacokinetics, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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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.
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Who cites it
15 citing papers in PubMed.
- Pilot Study of Model-Based Dosage Individualization of Ganciclovir in Neonates and Young Infants with Congenital Cytomegalovirus Infection.Antimicrobial agents and chemotherapy · 2018Trial
- Population pharmacokinetics and Bayesian estimator of mycophenolic acid in children with idiopathic nephrotic syndrome.British journal of clinical pharmacology · 2010Trial
- Article
- Validated Erythrosin B spectrofluorimetric method for ganciclovir bioanalysis in rabbit plasma following valganciclovir bioconversion and Pharmacokinetic application.Scientific reports · 2025Article
- Serum ganciclovir drug exposure in children receiving standard ganciclovir dosing.Antimicrobial agents and chemotherapy · 2024Article
- Establishment and Evaluation of a Parametric Population Pharmacokinetic Model Repository for Ganciclovir and Valganciclovir.Pharmaceutics · 2023Article
- Limited Sampling Strategies to Predict Ganciclovir Exposure after Valganciclovir Administration and to Reduce Monitoring Constraints in Renal Transplant Children.Antimicrobial agents and chemotherapy · 2023Article
- Population Pharmacokinetics of Ganciclovir in Allogeneic Hematopoietic Stem Cell Transplant Patients.Antimicrobial agents and chemotherapy · 2023Observational
- Therapeutic Drug Monitoring of Ganciclovir: Where Are We?Therapeutic drug monitoring · 2022Review
- Thoroughly Validated Bayesian Estimator and Limited Sampling Strategy for Dose Individualization of Ganciclovir and Valganciclovir in Pediatric Transplant Recipients.Clinical pharmacokinetics · 2021Article
- Population pharmacokinetics of ganciclovir after valganciclovir in renal transplant children.Antimicrobial agents and chemotherapy · 2019Article
- Population pharmacokinetics of valganciclovir prophylaxis in paediatric and adult solid organ transplant recipients.British journal of clinical pharmacology · 2014Article
- Pharmacokinetics of ganciclovir and valganciclovir in the adult horse.Journal of veterinary pharmacology and therapeutics · 2013Article
- Adaptive trials in paediatric development: dealing with heterogeneity and uncertainty in pharmacokinetic differences in children.British journal of clinical pharmacology · 2012Article
- 24 weeks of valganciclovir prophylaxis in children after renal transplantation: a 4-year experience.Transplantation · 2011Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo develop a population pharmacokinetic model for valganciclovir in paediatric renal transplant recipients, identify covariates that explain variability, and determine valganciclovir dosage regimens for cytomegalovirus (CMV) prophylaxis in children.
methodsThe pharmacokinetics of valganciclovir were described with plasma concentrations from 22 patients (age range 3-17 years) using nonlinear mixed-effects modelling (NONMEM) software. A two-compartment model with lag-time and first-order absorption and elimination was developed. The final model was validated using a bootstrap and visual predictive check. The dosage regimens of valganciclovir for CMV prophylaxis in children were simulated using the final model.
resultsThe mean population pharmacokinetic parameters were apparent systemic clearance (CL) 10.1L/h, apparent central volume of distribution 5.2 L, apparent peripheral volume of distribution 30.7 L, inter-tissue clearance 3.97 L/h, absorption rate constant 0.369 h-1 and lag-time 0.743 h. The covariate analysis identified creatinine clearance (CL(CR)) and bodyweight (WT) as individual factors influencing the apparent oral clearance: CL= 8.04 x (CL(CR)/89)(2.93) + 3.62 x (WT/28) L/h. The results of the simulation showed that for a typical patient (WT 28 kg and CL(CR) 89 mL/min), an area under the plasma concentration-time curve of 43 +/- 10.6 mg x h/mL will be achieved with valganciclovir 500 mg once daily.
conclusionThe dosage regimens of valganciclovir for CMV prophylaxis have been defined using the final population pharmacokinetic model based on WT and CLCR for paediatric renal transplantation patients.
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