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

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20268656

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