Kidney Transplantation Cytomegalovirus (CMV) Negative RecipientsPhase 2NCT01974206
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 Phase 2 study testing ASP0113 in people with Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients, run by Astellas Pharma Global Development, Inc. at 53 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
- What is being tested?
- ASP0113
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 53 sitesin 6 countries
- Study dates
- 20 Nov 2013to 5 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
53 sites in 6 countries.
53 sites in 6 countries
United States33 sites
Site US10023
Ann Arbor, Michigan, 48109-5364
Site US10058
Atlanta, Georgia, 30309
Site US10013
Atlanta, Georgia, 30322
Site US10044
Aurora, Colorado, 80045
Site US10045
Buffalo, New York, 14215
Site US10047
Charleston, South Carolina, 29425
Site US10038
Charlottesville, Virginia, 22903
Site US10030
Chicago, Illinois, 60612
Site US10009
Chicago, Illinois, 60637
Site US10001
Cleveland, Ohio, 44106
Site US10048
Detroit, Michigan, 48202
Site US10050
Greenville, North Carolina, 27858
Site US10028
Houston, Texas, 77030
Site US10057
Indianapolis, Indiana, 46202
Site US10046
Lexington, Kentucky, 40536
Site US10003
Los Angeles, California, 90057
Site US10029
Madison, Wisconsin, 53792
Site US10027
Nashville, Tennessee, 37232
Site US10018
New Haven, Connecticut, 06520
Site US10041
New Orleans, Louisiana, 70121
Site US10015
Omaha, Nebraska, 68198
Site US10026
Phoenix, Arizona, 85054
Site US10042
Pittsburgh, Pennsylvania, 15213
Site US10049
Portland, Maine, 04102
Site US10031
Richmond, Virginia, 23298
Site US10014
Salt Lake City, Utah, 84132
Site US10004
San Diego, California, 92123
Site US10036
San Francisco, California, 94115
Site US10037
San Francisco, California, 94143
Site US10020
Seattle, Washington, 98101
Site US10011
Seattle, Washington, 98195-6175
Site US10016
St Louis, Missouri, 63110
Site US10012
The Bronx, New York, 10467
Germany5 sites
Site DE49002
Berlin, 10117
Site DE49001
Berlin, 13353
Site DE49008
Bonn, 53105
Site DE49003
Erlangen, 91054
Site DE49005
Hamburg, 20246
Canada4 sites
Site CA15003
Halifax, Nova Scotia, B3H 1V8
Site CA15005
London, Ontario, N6A 4V2
Site CA15006
Toronto, Ontario, M5G2N2
Site CA15004
Vancouver, British Columbia, V6Z 1Y6
France4 sites
Site FR33005
Bordeaux, 33000
Site FR33003
Montpellier, 34295
Site FR33004
Nantes, 44000
Site FR33001
Nice, 66001
Spain4 sites
Site ES34003
Barcelona, 08003
Site ES34002
Barcelona, 08035
Site ES34001
Barcelona, 8907
Site ES34004
Zaragoza, 50009
Australia3 sites
Site AU61001
Adelaide SA, South Australia, 5000
Site AU61002
Sydney, New South Wales, NSW 2050
Site AU61004
Woolloongabba, Queensland, QLD 4102
About this study
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
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.
Read the 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.
- Being tested
- ASP0113, Placebo
- Keywords
- ASP0113, Cytomegalovirus (CMV), Kidney Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP0113Biological
intramuscular injection
PlaceboDrug
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| ASP0113 | Experimental | 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). Receives: Biological: ASP0113 |
| Placebo | Placebo comparator | 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
An independent panel of medical experts reviewed/adjudicated events of CMV-specific AVT for treatment of CMV viremia or disease.
Measured: 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)
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.
Measured: 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)
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.
Measured: Month 18, 30, 42, 54, and 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study start20 Nov 2013
- Primary completion13 May 2016
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplantation Cytomegalovirus (CMV) Negative RecipientsStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vical
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974206
- Sponsor's protocol ID
- 0113-CL-2001
- Other IDs
- 2013-000464-29
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2013
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/.
Publications
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.
PubMed 29745007
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01974206
- Acronym / sponsor ID
- 0113-CL-2001
- Keywords
- ASP0113, Cytomegalovirus (CMV), Kidney Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vical
- Study start
- 20 Nov 2013 (actual)
- Primary completion
- 13 May 2016 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Posted 4 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP0113 | Experimental | Biological: ASP0113Participants 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 comparator | Drug: PlaceboParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP0113intramuscular injection | Biological | ASP0113 |
| Placebointramuscular injection | Drug | Placebo |
Primary outcome
Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection
Time frame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
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.
5 secondary outcomes
Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Month 18, 30, 42, 54, and 66
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29745007Vincenti 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.
- Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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/.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development, Inc.
53 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP0113 in people with Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients, run by Astellas Pharma Global Development, Inc. at 53 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Germany, Canada, France, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection (time frame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01974206, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.