Back to resultsA 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
Primary Purpose
Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ASP0113
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients focused on measuring ASP0113, Cytomegalovirus (CMV), Kidney Transplantation
Eligibility Criteria
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.
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.
Sites / Locations
- Site US10026
- Site US10003
- Site US10004
- Site US10036
- Site US10037
- Site US10044
- Site US10018
- Site US10058
- Site US10013
- Site US10030
- Site US10009
- Site US10057
- Site US10046
- Site US10041
- Site US10049
- Site US10023
- Site US10048
- Site US10016
- Site US10015
- Site US10012
- Site US10045
- Site US10050
- Site US10001
- Site US10042
- Site US10047
- Site US10027
- Site US10028
- Site US10014
- Site US10038
- Site US10031
- Site US10020
- Site US10011
- Site US10029
- Site AU61002
- Site AU61004
- Site AU61001
- Site CA15004
- Site CA15003
- Site CA15005
- Site CA15006
- Site FR33005
- Site FR33003
- Site FR33004
- Site FR33001
- Site DE49002
- Site DE49001
- Site DE49008
- Site DE49003
- Site DE49005
- Site ES34003
- Site ES34002
- Site ES34001
- Site ES34004
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ASP0113
Placebo
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)
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.
Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)
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.
Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)
An independent panel of medical experts reviewed/adjudicated events of CMV-specific AVT for treatment of CMV viremia or disease.
Percentage of Participants With Graft Survival (Primary Study Period)
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.
Percentage of Participants With Graft Survival (Long-term Follow up)
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.
Full Information
NCT ID
NCT01974206
First Posted
October 28, 2013
Last Updated
February 16, 2022
Sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Vical
1. Study Identification
Unique Protocol Identification Number
NCT01974206
Brief 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
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2013 (Actual)
Primary Completion Date
May 13, 2016 (Actual)
Study Completion Date
November 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Vical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Participants were followed for one year after first study drug injection. This was the primary study period.
Participants were followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
Keywords
ASP0113, Cytomegalovirus (CMV), Kidney Transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP0113
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
ASP0113
Intervention Description
intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intramuscular injection
Primary Outcome Measure Information:
Title
Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection
Description
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.
Time Frame
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)
Description
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.
Time Frame
From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection
Title
Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)
Description
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.
Time Frame
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Title
Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)
Description
An independent panel of medical experts reviewed/adjudicated events of CMV-specific AVT for treatment of CMV viremia or disease.
Time Frame
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Title
Percentage of Participants With Graft Survival (Primary Study Period)
Description
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.
Time Frame
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Title
Percentage of Participants With Graft Survival (Long-term Follow up)
Description
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.
Time Frame
Month 18, 30, 42, 54, and 66
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Global Development, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site US10026
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Site US10003
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Site US10004
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site US10036
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Site US10037
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Site US10044
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Site US10018
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Site US10058
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Site US10013
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Site US10030
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Site US10009
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Site US10057
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Site US10046
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Site US10041
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Site US10049
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Site US10023
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5364
Country
United States
Facility Name
Site US10048
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Site US10016
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site US10015
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Site US10012
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Site US10045
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Site US10050
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Site US10001
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Site US10042
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Site US10047
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Site US10027
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Site US10028
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site US10014
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Site US10038
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Site US10031
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Site US10020
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Site US10011
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6175
Country
United States
Facility Name
Site US10029
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Site AU61002
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
NSW 2050
Country
Australia
Facility Name
Site AU61004
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
QLD 4102
Country
Australia
Facility Name
Site AU61001
City
Adelaide SA
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Site CA15004
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Site CA15003
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V8
Country
Canada
Facility Name
Site CA15005
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Site CA15006
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2N2
Country
Canada
Facility Name
Site FR33005
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Site FR33003
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Site FR33004
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Site FR33001
City
Nice
ZIP/Postal Code
66001
Country
France
Facility Name
Site DE49002
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Site DE49001
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Site DE49008
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Site DE49003
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Site DE49005
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Site ES34003
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Site ES34002
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Site ES34001
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Site ES34004
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
29745007
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicaltrials.astellas.com/study/?pid=0113-CL-2001
Description
Link to results and other applicable study documents on the Astellas Clinical Trials website
URL
https://www.trialsummaries.com/Study/StudyDetails?id=14616&tenant=MT_AST_9011
Description
Link to plain language summary of the study on the Trial Results Summaries website
Learn more about this trial
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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