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
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
2 other identifiers
interventional
150
6 countries
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2013
Longer than P75 for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2013
CompletedStudy Start
First participant enrolled
November 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2020
CompletedResults Posted
Study results publicly available
January 4, 2022
CompletedOctober 24, 2024
October 1, 2024
2.5 years
October 28, 2013
October 21, 2021
October 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection
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.
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Secondary Outcomes (5)
Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)
From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection
Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Percentage of Participants With Graft Survival (Primary Study Period)
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Percentage of Participants With Graft Survival (Long-term Follow up)
Month 18, 30, 42, 54, and 66
Study Arms (2)
ASP0113
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Global Development, Inc.lead
- Vicalcollaborator
Study Sites (53)
Site US10026
Phoenix, Arizona, 85054, United States
Site US10003
Los Angeles, California, 90057, United States
Site US10004
San Diego, California, 92123, United States
Site US10036
San Francisco, California, 94115, United States
Site US10037
San Francisco, California, 94143, United States
Site US10044
Aurora, Colorado, 80045, United States
Site US10018
New Haven, Connecticut, 06520, United States
Site US10058
Atlanta, Georgia, 30309, United States
Site US10013
Atlanta, Georgia, 30322, United States
Site US10030
Chicago, Illinois, 60612, United States
Site US10009
Chicago, Illinois, 60637, United States
Site US10057
Indianapolis, Indiana, 46202, United States
Site US10046
Lexington, Kentucky, 40536, United States
Site US10041
New Orleans, Louisiana, 70121, United States
Site US10049
Portland, Maine, 04102, United States
Site US10023
Ann Arbor, Michigan, 48109-5364, United States
Site US10048
Detroit, Michigan, 48202, United States
Site US10016
St Louis, Missouri, 63110, United States
Site US10015
Omaha, Nebraska, 68198, United States
Site US10045
Buffalo, New York, 14215, United States
Site US10012
The Bronx, New York, 10467, United States
Site US10050
Greenville, North Carolina, 27858, United States
Site US10001
Cleveland, Ohio, 44106, United States
Site US10042
Pittsburgh, Pennsylvania, 15213, United States
Site US10047
Charleston, South Carolina, 29425, United States
Site US10027
Nashville, Tennessee, 37232, United States
Site US10028
Houston, Texas, 77030, United States
Site US10014
Salt Lake City, Utah, 84132, United States
Site US10038
Charlottesville, Virginia, 22903, United States
Site US10031
Richmond, Virginia, 23298, United States
Site US10020
Seattle, Washington, 98101, United States
Site US10011
Seattle, Washington, 98195-6175, United States
Site US10029
Madison, Wisconsin, 53792, United States
Site AU61002
Sydney, New South Wales, NSW 2050, Australia
Site AU61004
Woolloongabba, Queensland, QLD 4102, Australia
Site AU61001
Adelaide SA, South Australia, 5000, Australia
Site CA15004
Vancouver, British Columbia, V6Z 1Y6, Canada
Site CA15003
Halifax, Nova Scotia, B3H 1V8, Canada
Site CA15005
London, Ontario, N6A 4V2, Canada
Site CA15006
Toronto, Ontario, M5G2N2, Canada
Site FR33005
Bordeaux, 33000, France
Site FR33003
Montpellier, 34295, France
Site FR33004
Nantes, 44000, France
Site FR33001
Nice, 66001, France
Site DE49002
Berlin, 10117, Germany
Site DE49001
Berlin, 13353, Germany
Site DE49008
Bonn, 53105, Germany
Site DE49003
Erlangen, 91054, Germany
Site DE49005
Hamburg, 20246, Germany
Site ES34003
Barcelona, 08003, Spain
Site ES34002
Barcelona, 08035, Spain
Site ES34001
Barcelona, 8907, Spain
Site ES34004
Zaragoza, 50009, Spain
Related Publications (1)
Vincenti F, Budde K, Merville P, Shihab F, Ram Peddi V, Shah M, Wyburn K, Cassuto-Viguier E, Weidemann A, Lee M, Flegel T, Erdman J, Wang X, Lademacher C. A randomized, phase 2 study of ASP0113, a DNA-based vaccine, for the prevention of CMV in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor. Am J Transplant. 2018 Dec;18(12):2945-2954. doi: 10.1111/ajt.14925. Epub 2018 Jun 20.
PMID: 29745007DERIVED
Related Links
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2013
First Posted
November 1, 2013
Study Start
November 20, 2013
Primary Completion
May 13, 2016
Study Completion
November 5, 2020
Last Updated
October 24, 2024
Results First Posted
January 4, 2022
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- 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.
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 products 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. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.