CMV Immunity Monitoring in Lung Transplant Recipients

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05708755
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lung Transplant; Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Cytomegalovirus T Cell Immunity Panel (CMV-TCIP) — DEVICE
    Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).
  • Donor-Derived Cell-Free DNA (dd-cfDNA) Assay — DIAGNOSTIC_TEST
    Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.
  • Valganciclovir — DRUG
    Delivered as standard of care for post-lung transplant immunosuppression and infection prophylaxis. Started on the first day post-transplant at a standard dose of 900 mg daily and continued for 12 months. Dose adjustments may be necessary based on renal function and/or adverse effects (e.g. neutropenia). Dose adjustments are standard based on package insert recommendations.

Study Details

The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.

Key Dates

Start date
Sep 13, 2024
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Lung Transplant Recipients
    Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded.

Primary Outcome Measure

CMV Viremia-Free Survival [ Time Frame: Up to Month 12 Post-Transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Tyler Lewis
[email protected]
866-838-5864

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By research site
NYU Langone Health· New York, NY

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