Trial Outcomes & Findings for Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients (NCT NCT02503982)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

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

Results posted on

2017-04-04

Participant Flow

conducted at the Schneider Children's Medical Center (SCMC) from December 2014 to August 2015.

A prospective pharmacokinetic. age \<18 years of age, GFR\>60 mL/min/1.73m2, solid-organ transplantation and oral VGC prophylaxis for CMV infection

Participant milestones

Participant milestones
Measure	Solid Organ Transplanted Children Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg. prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Solid Organ Transplanted Children n=13 Participants Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg. prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.
Age, Categorical <=18 years	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	7.3 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Solid Organ Transplanted Children n=13 Participants Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg. prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.
Area Under the Curve (AUC)	21.0 mcg∙h/mL Interval 17.1 to 39.8

Adverse Events

Solid Organ Transplanted Children

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Solid Organ Transplanted Children n=13 participants at risk Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg. prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.
Blood and lymphatic system disorders Hematologic toxicity	23.1% 3/13 • Number of events 3

Other adverse events

Adverse event data not reported

Additional Information

Dr. Liat Ashkenazi-Hoffnung

Schneider Children's Medical Center of Israel

Phone: 972-3-9253681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place