Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients

NCT02503982 | Completed Phase 4 Results

• 1 other identifier: 001-14-RMC
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 Blood was withdrawn at steady state: 2, 5 and 10 hours post dosing.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

Conditions

Infection in Solid Organ Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC)

  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.

  drug levels measured at 2, 5 and 10 h following administration of the dose on day 4 creating a 24 hours curve

Study Arms (1)

Solid Organ Transplanted children

EXPERIMENTAL

Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis, and stratified dose reductions for impaired renal function. Max dose was 900 mg.

Drug: prophylactic Valganciclovir

Interventions

prophylactic Valganciclovir DRUG

The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis, with stratified dose reductions for impaired renal function. Max dose was 900 mg.

Also known as: Valcyte

Solid Organ Transplanted children

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Treatment with ganciclovir IV
• Glomerular Filtration Rate (GFR) \< 60 mL/min/1.73 m2
• Imipenem treatment
• Cluster organ transplanted -

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider childrens medical center of Isreal

Petah Tikva, Israel

Location

Related Publications (1)

• Peled O, Berkovitch M, Rom E, Bilavsky E, Bernfeld Y, Dorfman L, Pappo A, Ziv-Baran T, Brandriss N, Bar-Haim A, Amir J, Ashkenazi-Hoffnung L. Valganciclovir Dosing for Cytomegalovirus Prophylaxis in Pediatric Solid-organ Transplant Recipients: A Prospective Pharmacokinetic Study. Pediatr Infect Dis J. 2017 Aug;36(8):745-750. doi: 10.1097/INF.0000000000001595.

  PMID: 28383392 DERIVED

MeSH Terms

Interventions

Valganciclovir

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Liat Ashkenazi-Hoffnung
• Organization: Schneider Children's Medical Center of Israel

LiatA3@clalit.org.il

972-3-9253681

Study Officials

• Liat Ashkenazy-Hofnung, MD

  Schneider's Children Medical center of Isreal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 21, 2015
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 4, 2017
• Results First Posted: June 30, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)