Phase 2
N=150
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
Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
Bottom Line
View on ClinicalTrials.gov: NCT01974206 ↗Enrolled (actual)
150
Serious AEs
53.7%
Results posted
Jan 2022
Primary outcome: Primary: Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection — 35.6; 35.6; 5.5; 0 Percentage of Paticipants — p=0.307
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ASP0113 (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Astellas Pharma Global Development, Inc.
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection |
35.6; 35.6; 5.5; 0 | 0.307 |
| SECONDARY Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period) |
19.18; 19.18 | 0.576 |
| SECONDARY Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period) |
49.32; 46.58 | 0.408 |
| SECONDARY Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period) |
45.21; 42.47 | 0.419 |
| SECONDARY Percentage of Participants With Graft Survival (Primary Study Period) |
98.53; 100 | 0.5 |
| SECONDARY Percentage of Participants With Graft Survival (Long-term Follow up) |
91.9; 94.7; 83.8; 81.6; 85.1; 80.3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01974206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.