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
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 13-007314
NCT ID: NCT01974206
Sponsor Protocol Number: 0113-CL-2001
About this study
The purpose of this study is 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 will also evaluate the safety of ASP0113 in this patient population.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- CMV negative subject having received a CMV seropositive kidney (living or deceased)
- Subject started valganciclovir or ganciclovir within 10 days of transplant and has received it through Randomization.
Exclusion Criteria:
- Subject is planned to undergo a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.
- Subject has received from one month prior to transplant or is planning to receive CMV immunoglobulin.
- Subject has had CMV viremia or CMV disease from time of transplant until time of Randomization.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Hasan Khamash, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available