NCT02503982

Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients - a Prospective Study

Completed Phase 4 Results posted Last updated 5 March 2017

What this trial tests

Phase 4 trial testing prophylactic Valganciclovir in Infection in Solid Organ Transplant Recipients in 13 participants. Completed in 1 August 2015.

Timeline

1 December 2014

Primary endpoint
1 August 2015

1 August 2015

Quick facts

Lead sponsor	Rabin Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	13
Start date	1 December 2014
Primary completion	1 August 2015
Estimated completion	1 August 2015
Sites	1 location across Israel

Drugs / interventions tested

• prophylactic Valganciclovir — full drug profile →

Conditions studied

• Infection in Solid Organ Transplant Recipients — all drugs for Infection in Solid Organ Transplant Recipients →

Sponsor

Rabin Medical Center

Who can join

Under 17, any sex, with Infection in Solid Organ Transplant Recipients. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Area Under the Curve (AUC)
  Time frame: drug levels measured at 2, 5 and 10 h following administration of the dose on day 4 creating a 24 hours curve
  Valganciclovir area under the curve (AUC) calculated with the trapezoidal method using drug levels measured at 2, 5 and 10 h, and extrapolated beyond the 10 hour time point to arrive at a 24-hour curve.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.