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

• Status: Completed
• Trial end date: 2013-05-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ganciclovir; Valganciclovir

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