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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01376804
Registration number
NCT01376804
Ethics application status
Date submitted
17/06/2011
Date registered
20/06/2011
Date last updated
11/07/2017
Titles & IDs
Public title
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
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Scientific title
Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
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Secondary ID [1]
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2010-022514-47
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Secondary ID [2]
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NV25409
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation, Cytomegalovirus Infections
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - valganciclovir [Valcyte]
Experimental: Valganciclovir - Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in milligrams) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Treatment: Drugs: valganciclovir [Valcyte]
Oral, daily for up to 200 days.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs
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Assessment method [1]
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An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs.
A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
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Timepoint [1]
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52 weeks
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Secondary outcome [1]
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Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator
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Assessment method [1]
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A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia (presence of CMV in the blood) by each study center as part of the clinical assessment required for diagnosis of CMV infection.
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Timepoint [1]
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52 weeks
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Secondary outcome [2]
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Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator
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Assessment method [2]
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A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia by each study center as part of the clinical assessment required for diagnosis of CMV infection. CMV disease included CMV syndrome or tissue invasive CMV. CMV syndrome required fever = 38 degrees Celsius, severe malaise, leukopenia on 2 separate measurements, atypical lymphocytosis = 5%, thrombocytopenia, elevation of hepatic transaminases and presence of CMV in blood. Tissue Invasive CMV required evidence of localized CMV infection in a biopsy or other appropriate symptom and relevant symptoms or signs of organ dysfunction.
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Timepoint [2]
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52 weeks
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Secondary outcome [3]
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Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant
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Assessment method [3]
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Blood samples were sent to a central lab for the quantitative assessment of CMV viral load (amount of CMV in the blood) by an FDA-approved molecular-based assay. The number of participants in each category is reported in copies/milliliter (CP/mL). CMV DNA is detected in all categories < 150 CP/mL and above.
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Timepoint [3]
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52 weeks
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Secondary outcome [4]
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Number of Participants With Biopsy Proven Rejection
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Assessment method [4]
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Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.
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Timepoint [4]
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52 Weeks
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Secondary outcome [5]
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Number of Participants With Graft Loss
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Assessment method [5]
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Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.
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Timepoint [5]
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52 Weeks
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Secondary outcome [6]
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Number of Participants With Death
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Assessment method [6]
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Timepoint [6]
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52 Weeks
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Secondary outcome [7]
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Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)
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Assessment method [7]
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All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.
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Timepoint [7]
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52 Weeks
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Eligibility
Key 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
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Minimum age
4
Months
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/07/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/05/2013
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Sample size
Target
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Accrual to date
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Final
57
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Children'S Hospital At Westmead; Department of Nephrology - Westmead
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Recruitment hospital [2]
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Mater Childrens Hospital - South Brisbane, Herston
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Recruitment hospital [3]
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Royal Children'S Hospital; Department of Nephrology - Parkville
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4029 - South Brisbane, Herston
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Louisiana
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Country [3]
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United States of America
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New York
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Country [4]
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United States of America
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Utah
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Country [5]
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Brazil
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SP
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Country [6]
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France
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State/province [6]
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Nantes
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Country [7]
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France
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State/province [7]
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Paris
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Köln
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Mexico
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State/province [12]
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Aguascalientes
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Mexico
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State/province [13]
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Cuernavaca
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Country [14]
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Mexico
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State/province [14]
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Mexico
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Country [15]
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Spain
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State/province [15]
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Barcelona
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Country [16]
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Spain
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State/province [16]
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Madrid
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Country [17]
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Spain
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State/province [17]
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Sevilla
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Sweden
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State/province [18]
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Göteborg
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United Kingdom
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Birmingham
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Country [20]
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United Kingdom
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Bristol
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Country [21]
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United Kingdom
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State/province [21]
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Glasgow
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01376804
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01376804
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