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

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Medical Conditions
  • Kidney Transplantation, Cytomegalovirus Infections
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01376804

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Bristol Royal Hospital for Children
Bristol
England
BS2 8BJ
Birmingham
B4 6NH
University of Glasgow
Glasgow
G3 8SJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Brazil, France, Germany, Mexico, Spain, Sweden, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 added to source

17 Jun 2011

Date updated in source

27 Mar 2014