At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Individualization of Ganciclovir and Valganciclovir Doses in Renal Transplant Patients for Prophylaxis or Treatment of Cytomegalovirus(CMV)Infection Using Bayesian Prediction.
In Brief
A Phase 4 clinical trial evaluating Ganciclovir/ Valganciclovir according to SPC and Ganciclovir/ Valganciclovir according to PK model for Infection in Solid Organ Transplant Recipients. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Doses according to Summaries of Product Characteristics (SPC)
Doses according to population pharmacokinetic model