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

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.

Brief Title

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.

Categories

Kidney & Urinary Tract

Hepatitis

COVID-19

Infectious Disease

Completion Date

2020-11-05

Completion Date Type

Actual

Conditions

Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients

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.

Inclusion 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.

Gender

All

Gender Based

false

Keywords

ASP0113

Cytomegalovirus (CMV)

Kidney Transplantation

Healthy Volunteers

No

Last Update Post Date

Thu, 10/24/2024 - 12:00

Last Update Post Date Type

Actual

Last Update Submit Date

Tue, 10/15/2024 - 12:00

Minimum Age

18 Years

NCT Id

NCT01974206

Org Class

Industry

Org Full Name

Astellas Pharma Inc

Org Study Id

0113-CL-2001

Overall Status

Completed

Phases

Phase 2

Primary Completion Date

Fri, 05/13/2016 - 12:00

Primary Completion Date Type

Actual

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

Primary Outcomes

Outcome 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.

Outcome Measure

Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection

Outcome Time Frame

From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

Secondary Ids

Secondary Id

2013-000464-29

Secondary Outcomes

Outcome 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.

Outcome Time Frame

From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection

Outcome Measure

Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)

Outcome 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.

Outcome Time Frame

From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

Outcome Measure

Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)

Outcome Description

An independent panel of medical experts reviewed/adjudicated events of CMV-specific AVT for treatment of CMV viremia or disease.

Outcome Time Frame

From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

Outcome Measure

Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)

Outcome 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.

Outcome Time Frame

From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

Outcome Measure

Percentage of Participants With Graft Survival (Primary Study Period)

Outcome 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.

Outcome Time Frame

Month 18, 30, 42, 54, and 66

Outcome Measure

Percentage of Participants With Graft Survival (Long-term Follow up)