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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/NCT01974206
Registration number
NCT01974206
Ethics application status
Date submitted
28/10/2013
Date registered
1/11/2013
Date last updated
17/02/2022
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
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Secondary ID [1]
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2013-000464-29
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Secondary ID [2]
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0113-CL-2001
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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 (CMV) Negative Recipients
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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
Other interventions - ASP0113
Treatment: Drugs - Placebo
Experimental: ASP0113 - Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Placebo Comparator: Placebo - Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Other interventions: ASP0113
intramuscular injection
Treatment: Drugs: Placebo
intramuscular injection
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Intervention code [1]
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Other interventions
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Intervention code [2]
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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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Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection
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Assessment method [1]
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CMV viremia was defined as presence of cytomegalovirus as measured in plasma viral load of = 1000 IU/mL by central laboratory assay. A participant who discontinued the study without a positive CMV viral load was imputed as having a CMV viremia. A participant who had more than one viral load = 1000 IU/mL by central assay was counted once in this summary. CMV viral loads after first injection (Day 1) through Day 380 (scheduled or unscheduled) were included in the analysis.
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Timepoint [1]
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From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
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Secondary outcome [1]
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Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)
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Assessment method [1]
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An independent panel of medical experts reviewed/adjudicated events of CMV-associated disease including CMV syndrome and tissue invasive disease, which were defined according to the American Society of Transplantation Recommendations for Screening, Monitoring and Reporting of Infectious Complications in Immunosuppression Trials in Recipients of Organ Transplantation 2006.
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Timepoint [1]
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From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection
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Secondary outcome [2]
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Percentage of Participants With Plasma Viral Load = The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)
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Assessment method [2]
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The central laboratory had the LLOQ level for CMV viral load assessment. When the viral load was below the LLOQ the actual reading was not possible and was denoted as =LLOQ. If the participant had any CMV viral load assessments greater than the LLOQ, set up by the central laboratory, participant was classified as viremic and was included in the analysis.
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Timepoint [2]
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From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
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Secondary outcome [3]
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Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)
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Assessment method [3]
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An independent panel of medical experts reviewed/adjudicated events of CMV-specific AVT for treatment of CMV viremia or disease.
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Timepoint [3]
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From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
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Secondary outcome [4]
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Percentage of Participants With Graft Survival (Primary Study Period)
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Assessment method [4]
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Graft survival was defined for any participant that did not fit the definition of graft loss. Graft loss was defined as participant death, re-transplant, nephrectomy, or return to permanent dialysis (i.e., for > 30 days). Missing values for graft survival were not included in the denominator when making the proportion. The analysis population was the FAS.
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Timepoint [4]
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From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
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Secondary outcome [5]
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Percentage of Participants With Graft Survival (Long-term Follow up)
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Assessment method [5]
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Graft survival was defined for any participant that did not fit the definition of graft loss. Graft loss was defined as participant death, re-transplant, nephrectomy, or return to permanent dialysis (i.e., for > 30 days). Missing values for graft survival were not included in the denominator when making the proportion.
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Timepoint [5]
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Month 18, 30, 42, 54, and 66
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Eligibility
Key inclusion criteria
- CMV negative subject having received a CMV seropositive kidney (living or deceased)
- Participant started valganciclovir or ganciclovir within 10 days of transplant and had
received it through Randomization.
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Minimum age
18
Years
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Maximum age
No limit
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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
- Participant underwent a course of CMV-specific prophylactic therapy with antiviral
drugs with a duration of greater than 100 days.
- Participant had received from one month prior to transplant or planned to receive CMV
immunoglobulin.
- Participant had CMV viremia or CMV disease from time of transplant until time of
Randomization.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
20/11/2013
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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
5/11/2020
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Sample size
Target
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Accrual to date
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Final
150
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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Site AU61002 - Sydney
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Recruitment hospital [2]
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Site AU61004 - Woolloongabba
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Recruitment hospital [3]
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Site AU61001 - Adelaide SA
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Recruitment postcode(s) [1]
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NSW 2050 - Sydney
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Recruitment postcode(s) [2]
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QLD 4102 - Woolloongabba
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Recruitment postcode(s) [3]
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5000 - Adelaide SA
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Ontario
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Bordeaux
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France
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Nantes
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Nice
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Berlin
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Bonn
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Barcelona
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Spain
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Zaragoza
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Astellas Pharma Global Development, Inc.
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Address
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Commercial sector/Industry
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Vical
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Ethics approval
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Summary
Brief summary
The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in
reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects
receiving a kidney from a CMV-seropositive donor. This study also evaluated the safety of
ASP0113 in this patient population.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01974206
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Astellas Pharma Global Development, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01974206
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