Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant Patients.
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
The objective of the present study is to optimize intravenous ganciclovir(GCV) and oral
valganciclovir (VGCV)doses, advised by the drug exposure, indicated by the area under the
concentration time curve (AUC), in renal transplant patients receiving oral VGCV or
intravenous GCV for CMV prophylaxis or treatment. The initial doses will be calculated
according to population pharmacokinetic model. Subsequent doses will be adjusted according to
plasma GCV concentrations, using the Bayesian approach. This method of dose adjustments could
lead to increase the percentage of patients achieving a therapeutic exposure.
Phase:
Phase 4
Details
Lead Sponsor:
Nuria Lloberas
Collaborator:
Ministerio de Sanidad, Servicios Sociales e Igualdad