A Study to Evaluate the Effectiveness of VERIS CMV Assay to Measure Cytomegalovirus (CMV) as an Aid for Monitoring the Response of the Virus to Therapy
Overview
Tab Title Description
Study type
ObservationalDescribes 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: 16-007378
Sponsor Protocol Number: CMV-01-16
About this study
The purpose of this study is to evaluate the safety and effectiveness of the VERIS CMV Assay as an aid in the management of anti-CMV treatment for solid organ transplant patients by showing that virus levels are in agreement with the observed clinical status.
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
- Written Informed Consent obtained
- Male or Female
- Any race or ethnicity
- ≥ 18 years old
- Must have had a kidney transplant and has been evaluated for post-transplantation care
- Must have demonstrated post-transplant CMV DNAemia detected by a FDA approved CMV-PCR test
- Must be eligible for and treated with anti-CMV drugs (e.g. ganciclovir and/or valganciclovir)
Exclusion Criteria
- HIV positive by serology
- Proven ganciclovir or valganciclovir resistance
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