Clinical Performance Evaluation of DxN CMV Assay

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03127787

Enrollment

Registered

2017-04-25

Start date

2016-06-30

Completion date

2017-08-30

Last updated

2018-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus

Brief summary

The DxN Cytomegalovirus (CMV) assay is an in vitro diagnostic assay intended as an aid in the management of CMV-infected individuals undergoing antiviral therapy. the purpose of the study is to establish the clinical performance of the DxN CMV Assay for plasma samples in the intended use population.

Detailed description

same as brief summary

Interventions

DIAGNOSTIC_TESTCMV Assay

Molecular diagnostic test to detect CMV

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥ 18 years old * Must have had a kidney transplant and be evaluated for post-transplantation care * Must have demonstrated post-transplant CMV DNAemia * Must be eligible for and treated with anti-CMV drugs

Exclusion criteria

* HIV positive * Proven ganciclovir or valganciclovir resistance

Design outcomes

Primary

Measure	Time frame	Description
virological response to therapy	5 months	Resolution of CMV viremia in response to therapy as defined as 2 consecutive negative results

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026