CompletedPhase 4

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

United States, Australia57 participantsStarted 2011-07-31

Plain-language 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.

Who can participate

Age range4 Months – 16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs

Timeframe: 52 weeks

Trial details

NCT IDNCT01376804

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-05-31

Results submitted2014-03-27

View on ClinicalTrials.gov More Kidney Transplantation, Cytomegalovirus Infections trials