Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients
Tab Title Description
Describes 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.
- 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.
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. Please contact the study team to discuss whether or not you are eligible to participate in a study.
- 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
- 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
Mayo Clinic principal investigator
Raymund Razonable, M.D.
Closed for enrollment
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available