Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients
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
- Rochester, Minnesota: 15-009199
NCT ID: NCT02784756
Sponsor Protocol Number: UHN-TID-003
About this study
The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.
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:
- Adult kidney, kidney-pancreas, liver transplant recipient, or heart transplant recipient
- CMV D+/R- patient or any R+ patient who received antithymocyte globulin induction therapy
Exclusion Criteria:
- Unable to comply with protocol
- Campath (Alemtuzumab) induction
- Receiving another investigational compound for CMV treatment or prophylaxis.
- Allergy to valganciclovir or ganciclovir
- Receiving an investigational compound for prevention or treatment of rejection, or participating in another interventional study
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Raymund Razonable, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available