Study Stopped
Business decision
Clinical Performance Evaluation of DxN CMV Assay
1 other identifier
observational
19
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2016
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2017
CompletedJuly 12, 2018
July 1, 2018
1.2 years
April 17, 2017
July 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
virological response to therapy
Resolution of CMV viremia in response to therapy as defined as 2 consecutive negative results
5 months
Study Arms (1)
CMV infected
CMV infected observational study testing using DxN CMV Assay. Study is observational and results not used to manage patient care.
Interventions
Molecular diagnostic test to detect CMV
Eligibility Criteria
Adult kidney transplant recipients undergoing CMV therapy
You may qualify if:
- ≥ 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
You may not qualify if:
- HIV positive
- Proven ganciclovir or valganciclovir resistance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
UCLA
Los Angeles, California, United States
NWU
Chicago, Illinois, United States
IU
Indianapolis, Indiana, United States
Mayo
Rochester, Minnesota, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2017
First Posted
April 25, 2017
Study Start
June 1, 2016
Primary Completion
August 30, 2017
Study Completion
August 30, 2017
Last Updated
July 12, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share