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

  • Study type

    Observational
  • Study IDs

  • 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Raymund Razonable, M.D.

Open for enrollment

Contact information:

Maria Stevens

(507)255-3782

Stevens.Maria@mayo.edu

.
CLS-20268656

Mayo Clinic Footer