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Phase 4 Completed N=13 Prevention

Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients

Infection in Solid Organ Transplant Recipients
Source: ClinicalTrials.gov NCT02503982 ↗
Enrolled (actual)
13
Serious AEs
23.1%
Results posted
Jun 2016
Primary outcomePrimary: Area Under the Curve (AUC) — 21.0 mcg∙h/mL
◆ Published Evidence
Established
31citations · ~3 / year
Valganciclovir Dosing for Cytomegalovirus Prophylaxis in Pediatric Solid-organ Transplant Recipients: A Prospective Pharmacokinetic Study.
The Pediatric infectious disease journal · 2017 · Likely link

Summary

Valganciclovir is extensively used for cytomegalovirus (CMV) infection treatment and prophylaxis after solid organ transplantation (SOT). VGC dosing is problematic in children. valganciclovir has variable absorption and is renally excreted. Area Under the Curve (AUC) (0-24) of 40-60 mcg∙h/L is a predictive pharmacokinetic parameter of efficacy and safety. Dosing based on manufacturer recommendations is supra-therapeutic in most cases. A few published dosing algorithms result in AUC out of range. Objective: To prospectively validate a Valganciclovir administration dosing regimen and compare it to other dosing algorithms. Methods: Children after SOT at Schneider Children's Medical Center, the largest tertiary pediatric center in Israel, were prospectively studied, starting Dec 2014. The dosing regimen was derived from Seattle Children's Hospital guidelines; 14-16 mg/kg/dose. For impaired renal function, stratified dose reduction was used. Blood was withdrawn at steady state: 2, 5 and 10 hours post dosing. Drug level was analyzed by high pressure liquid chromatography (HPLC).

Linked Publications

  • Valganciclovir Dosing for Cytomegalovirus Prophylaxis in Pediatric Solid-organ Transplant Recipients: A Prospective Pharmacokinetic Study.
    The Pediatric infectious disease journal · 2017 · 31 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Curve (AUC)
21.0

Eligibility Criteria

Inclusion Criteria

  • children and adolescents 0-18 years old
  • Solid Organ Transplantation admitted after transplantation
  • Treatment with prophylactic Valganciclovir
  • Glomerular Filtration Rate (GFR) >= 60 mL/min/1.73 m2

Exclusion Criteria

  • Treatment with ganciclovir IV
  • Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2
  • Imipenem treatment
  • Cluster organ transplanted -
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02503982) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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