Phase 4 N=57 Prevention

A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients

Kidney Transplantation, Cytomegalovirus Infections

Bottom Line

View on ClinicalTrials.gov: NCT01376804 ↗

Enrolled (actual)

Serious AEs

73.2%

Results posted

Apr 2014

Primary outcome: Primary: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs — 56; 41; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: valganciclovir [Valcyte] (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs	56; 41; 6	—
SECONDARY Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator	3	—
SECONDARY Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator	1; 0	—
SECONDARY Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant	30; 16; 6; 3; 1	—
SECONDARY Number of Participants With Biopsy Proven Rejection	1; 1; 3	—
SECONDARY Number of Participants With Graft Loss	—	—
SECONDARY Number of Participants With Death	—	—
SECONDARY Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)	0; 1	—

Summary

This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.

Eligibility Criteria

Inclusion Criteria

Children, 4 months to 16 years of age
Patient has received a kidney transplant
At risk of developing cytomegalovirus disease
Adequate hematological and renal function
Able to tolerate oral medication
Negative pregnancy test for females of childbearing potential

Exclusion Criteria

Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
Severe uncontrolled diarrhea (more than 5 watery stools per day)
Liver enzyme elevation of more than five times the upper limit of normal for aspartate aminotransferase [AST (SGOT)] or alanine aminotransferase [ALT (SGPT)]
Patient requires use of any protocol prohibited concomitant medication
Previous participation in this clinical study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01376804). 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.