A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation, Cytomegalovirus Infections
Intervention: valganciclovir [Valcyte] (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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.
Clinical Details
Official title: Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs
Secondary outcome: Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the InvestigatorNumber of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant Number of Participants With Biopsy Proven Rejection Number of Participants With Graft Loss Number of Participants With Death Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)
Eligibility
Minimum age: 4 Months.
Maximum age: 16 Years.
Gender(s): Both.
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
Locations and Contacts
Nantes 44093, France
Paris 75019, France
Paris 75743, France
Hamburg 20246, Germany
Hannover 30625, Germany
Heidelberg 69120, Germany
Koeln 50924, Germany
Aguascalientes 20230, Mexico
Cuernavaca 62428, Mexico
Mexico 06720, Mexico
Barcelona 08035, Spain
Madrid 28046, Spain
Sevilla 41013, Spain
Göteborg 41345, Sweden
Birmingham B4 6NH, United Kingdom
Bristol BS2 8BJ, United Kingdom
Glasgow G3 8SJ, United Kingdom
Gainesville, Florida, United States
Los angeles, Louisiana 90095-1752, United States
Westmead, New South Wales 2145, Australia
New York, New York 10029-6574, United States
South Brisbane, Herston, Queensland 4029, Australia
Sao Paulo, SP 04038-002, Brazil
Salt Lake city, Utah 84108, United States
Parkville, Victoria 3052, Australia
Additional Information
Starting date: July 2011
Last updated: March 27, 2014
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