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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
Secondary ID [1] 0 0
2010-022514-47
Secondary ID [2] 0 0
NV25409
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation, Cytomegalovirus Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs - 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.
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator - 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.
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator - 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.
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant - 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.
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Number of Participants With Biopsy Proven Rejection - Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.
Timepoint [4] 0 0
52 Weeks
Secondary outcome [5] 0 0
Number of Participants With Graft Loss - Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.
Timepoint [5] 0 0
52 Weeks
Secondary outcome [6] 0 0
Number of Participants With Death
Timepoint [6] 0 0
52 Weeks
Secondary outcome [7] 0 0
Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes) - All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.
Timepoint [7] 0 0
52 Weeks

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
Minimum age
4 Months
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Children'S Hospital At Westmead; Department of Nephrology - Westmead
Recruitment hospital [2] 0 0
Mater Childrens Hospital - South Brisbane, Herston
Recruitment hospital [3] 0 0
Royal Children'S Hospital; Department of Nephrology - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - South Brisbane, Herston
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
Brazil
State/province [5] 0 0
SP
Country [6] 0 0
France
State/province [6] 0 0
Nantes
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Germany
State/province [8] 0 0
Hamburg
Country [9] 0 0
Germany
State/province [9] 0 0
Hannover
Country [10] 0 0
Germany
State/province [10] 0 0
Heidelberg
Country [11] 0 0
Germany
State/province [11] 0 0
Köln
Country [12] 0 0
Mexico
State/province [12] 0 0
Aguascalientes
Country [13] 0 0
Mexico
State/province [13] 0 0
Cuernavaca
Country [14] 0 0
Mexico
State/province [14] 0 0
Mexico
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Spain
State/province [17] 0 0
Sevilla
Country [18] 0 0
Sweden
State/province [18] 0 0
Göteborg
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Birmingham
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Bristol
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01376804
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications