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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01376804
First received: June 17, 2011
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Kidney Transplantation, Cytomegalovirus Infections
Drug: valganciclovir [Valcyte]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Tolerability: Incidence of adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of cytomegalovirus infection or disease in the first 52 weeks post-transplant [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Incidence of resistance to ganciclovir (mutations in both UL54 and UL97 genes) [ Time Frame: week 28 ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: July 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Drug: valganciclovir [Valcyte]
orally daily for up to 200 days

  Eligibility

Ages Eligible for Study:   4 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 AST (SGOT) or ALT (SGPT)
  • Patient requires use of any protocol prohibited concomitant medication
  • Previous participation in this clinical study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376804

  Show 25 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01376804     History of Changes
Other Study ID Numbers: NV25409, 2010-022514-47
Study First Received: June 17, 2011
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014