Actively Recruiting

Phase 2
Age: 18Years - 99Years
All Genders
ID05708755

Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients

Led by NYU Langone Health · Updated on 2026-05-29

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

V

Viracor Eurofins

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and feasibility of using a laboratory test called the inSIGHT12 CMV T Cell Immunity Panel to guide how long lung transplant recipients take antiviral medication called valganciclovir. The test measures immune responses to cytomegalovirus (CMV), a common viral infection. The goal is to safely reduce the duration of antiviral treatment after lung transplant based on the patient's immune response. Participants receive the CMV T Cell Immunity Panel test every three months after their lung transplant. Those with a certain immune response level may stop taking valganciclovir earlier than the standard 12 months. Valganciclovir is given daily starting the first day after transplant at a standard dose, with adjustments as needed for kidney function or side effects. Additional tests like donor-derived cell-free DNA assays are also used to monitor the transplant. During the study, participants will be closely monitored for CMV viremia-free survival over the first year after transplant, along with occurrences of CMV viremia, treatment-resistant CMV, and other infections such as bacterial pneumonia and Aspergillus. Researchers will track blood tests, immune function, and infection status to evaluate safety and effectiveness. The study is sponsored by NYU Langone Health and will continue until May 2028.

CONDITIONS

Brief Title

CMV Immunity Monitoring in Lung Transplant Recipients

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
  • Pre-existing serological immunity to CMV (R+)
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Anti-thymocyte globulin induction immunosuppression
  • Perioperative desensitization
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 months

Participants receive antiviral prophylaxis with Valganciclovir starting the first day post-transplant and continuing for 12 months. Dose adjustments may be made based on renal function or adverse effects.

Regular monitoring visits every 3 months for CMV-TCIP testing

Follow-up

Duration - Up to 12 months post-transplant

Participants are monitored for up to 12 months post-transplant for CMV viremia and related infections as part of the study outcomes.

Trial Site Locations

Total: 1 location

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

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Research Team

T

Tyler Lewis

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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