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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Kidney Transplantation, Cytomegalovirus Infections
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01376804
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
Phase 4
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Study Type
Interventional
Intervention
Drug : valganciclovir [Valcyte]

Study Arm Groups : Valganciclovir

Intervention Type
See Interventions above
Primary Outcome Measures
  • Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs; 52 weeks
Secondary Outcome Measures
  • Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator; 52 weeks; Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator; 52 weeks; Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant; 52 weeks; Number of Participants With Biopsy Proven Rejection; 52 Weeks; Number of Participants With Graft Loss; 52 Weeks; Number of Participants With Death; 52 Weeks; Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes); 52 Weeks
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
4 Months - 16 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Birmingham
West Midlands
B4 6NH
Royal Hospital for Sick Children
Glasgow
Glasgow City
G3 8SJ
Local Institution
Bristol
Avon
BS2 8BJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Australia, Brazil, France, Germany, Mexico, Spain, Sweden, United Kingdom
Scientific Title
Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
NV25409
Sponsor(s)
Hoffmann-La Roche
Key Dates

Recruitment Start Date

Jul 2011

Recruitment End Date

May 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

17 Jun 2011

Last Updated

27 Mar 2014