Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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 Blood was withdrawn at steady state: 2, 5 and 10 hours post dosing.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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Treatments: Ganciclovir; Valganciclovir

Criteria

Inclusion Criteria:

1. children and adolescents 0-18 years old

2. Solid Organ Transplantation admitted after transplantation

3. Treatment with prophylactic Valganciclovir

4. Glomerular Filtration Rate (GFR) >= 60 mL/min/1.73 m2

Exclusion Criteria:

1. Treatment with ganciclovir IV

2. Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2

3. Imipenem treatment

4. Cluster organ transplanted -