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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01974206




Registration number
NCT01974206
Ethics application status
Date submitted
28/10/2013
Date registered
1/11/2013

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
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
Secondary ID [1] 0 0
2013-000464-29
Secondary ID [2] 0 0
0113-CL-2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients 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: Other - 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).


Treatment: Other: ASP0113
intramuscular injection

Treatment: Drugs: Placebo
intramuscular injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection
Timepoint [1] 0 0
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Secondary outcome [1] 0 0
Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)
Timepoint [1] 0 0
From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection
Secondary outcome [2] 0 0
Percentage of Participants With Plasma Viral Load = The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)
Timepoint [2] 0 0
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Secondary outcome [3] 0 0
Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)
Timepoint [3] 0 0
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Secondary outcome [4] 0 0
Percentage of Participants With Graft Survival (Primary Study Period)
Timepoint [4] 0 0
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Secondary outcome [5] 0 0
Percentage of Participants With Graft Survival (Long-term Follow up)
Timepoint [5] 0 0
Month 18, 30, 42, 54, and 66

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
20/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/11/2020
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Site AU61002 - Sydney
Recruitment hospital [2] 0 0
Site AU61004 - Woolloongabba
Recruitment hospital [3] 0 0
Site AU61001 - Adelaide SA
Recruitment postcode(s) [1] 0 0
NSW 2050 - Sydney
Recruitment postcode(s) [2] 0 0
QLD 4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide SA
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Colorado
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United States of America
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Connecticut
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maine
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United States of America
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Michigan
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United States of America
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Missouri
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Nebraska
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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United States of America
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Virginia
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Washington
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United States of America
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Wisconsin
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Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Nova Scotia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
France
State/province [28] 0 0
Bordeaux
Country [29] 0 0
France
State/province [29] 0 0
Montpellier Cedex 5
Country [30] 0 0
France
State/province [30] 0 0
Nantes
Country [31] 0 0
France
State/province [31] 0 0
Nice
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Bonn
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Germany
State/province [34] 0 0
Erlangen
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Germany
State/province [35] 0 0
Hamburg
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Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Global Development, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Vical
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Astellas Pharma Global Development, Inc.
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Available to whom?
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01974206