Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients Clinical Trial
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
| Verified date | February 2022 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | November 5, 2020 |
| Est. primary completion date | May 13, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Site AU61001 | Adelaide SA | South Australia |
| Australia | Site AU61002 | Sydney | New South Wales |
| Australia | Site AU61004 | Woolloongabba | Queensland |
| Canada | Site CA15003 | Halifax | Nova Scotia |
| Canada | Site CA15005 | London | Ontario |
| Canada | Site CA15006 | Toronto | Ontario |
| Canada | Site CA15004 | Vancouver | British Columbia |
| France | Site FR33005 | Bordeaux | |
| France | Site FR33003 | Montpellier Cedex 5 | |
| France | Site FR33004 | Nantes | |
| France | Site FR33001 | Nice | |
| Germany | Site DE49001 | Berlin | |
| Germany | Site DE49002 | Berlin | |
| Germany | Site DE49008 | Bonn | |
| Germany | Site DE49003 | Erlangen | |
| Germany | Site DE49005 | Hamburg | |
| Spain | Site ES34001 | Barcelona | |
| Spain | Site ES34002 | Barcelona | |
| Spain | Site ES34003 | Barcelona | |
| Spain | Site ES34004 | Zaragoza | |
| United States | Site US10023 | Ann Arbor | Michigan |
| United States | Site US10013 | Atlanta | Georgia |
| United States | Site US10058 | Atlanta | Georgia |
| United States | Site US10044 | Aurora | Colorado |
| United States | Site US10012 | Bronx | New York |
| United States | Site US10045 | Buffalo | New York |
| United States | Site US10047 | Charleston | South Carolina |
| United States | Site US10038 | Charlottesville | Virginia |
| United States | Site US10009 | Chicago | Illinois |
| United States | Site US10030 | Chicago | Illinois |
| United States | Site US10001 | Cleveland | Ohio |
| United States | Site US10048 | Detroit | Michigan |
| United States | Site US10050 | Greenville | North Carolina |
| United States | Site US10028 | Houston | Texas |
| United States | Site US10057 | Indianapolis | Indiana |
| United States | Site US10046 | Lexington | Kentucky |
| United States | Site US10003 | Los Angeles | California |
| United States | Site US10029 | Madison | Wisconsin |
| United States | Site US10027 | Nashville | Tennessee |
| United States | Site US10018 | New Haven | Connecticut |
| United States | Site US10041 | New Orleans | Louisiana |
| United States | Site US10015 | Omaha | Nebraska |
| United States | Site US10026 | Phoenix | Arizona |
| United States | Site US10042 | Pittsburgh | Pennsylvania |
| United States | Site US10049 | Portland | Maine |
| United States | Site US10031 | Richmond | Virginia |
| United States | Site US10016 | Saint Louis | Missouri |
| United States | Site US10014 | Salt Lake City | Utah |
| United States | Site US10004 | San Diego | California |
| United States | Site US10036 | San Francisco | California |
| United States | Site US10037 | San Francisco | California |
| United States | Site US10011 | Seattle | Washington |
| United States | Site US10020 | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Global Development, Inc. | Vical |
United States, Australia, Canada, France, Germany, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection | |
| Secondary | 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. | From first study dose injection (day 1) up to one year post study drug injection (up to Day 380) | |
| Secondary | 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. | From first study dose injection (day 1) up to one year post study drug injection (up to Day 380) | |
| Secondary | 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. | From first study dose injection (day 1) up to one year post study drug injection (up to Day 380) | |
| Secondary | 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. | Month 18, 30, 42, 54, and 66 |