Recruiting

CMV Lung Transplant

Sponsor:

University of Alberta

Code:

NCT04439916

Conditions

Cytomegalovirus Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Cytomegalovirus (CMV) infection is the most common opportunistic infection in lung transplantation leading to direct and indirect effects that can result in life threatening complications. The risk of CMV infection is highest when the recipient of the transplant has never been in contact with CMV (negative immunity) and the donor had previous contact with CMV (positive immunity). This is called CMV mismatch. For these lung transplant patients 6 to 12 months of prophylaxis with an antiviral called Valganciclovir is recommended. This antiviral can cause side effects like bone marrow toxicity and decrease in immune cells which can result in temporarily having to stop the treatment. Starting and stopping the prophylaxis may result in the CMV becoming resistant to the medication. While taking the prophylaxis it is possible to have a breakthrough of the CMV, this is often due to the development of resistance to the antiviral. The purpose of this study is to learn more about the rate of CMV breakthrough while on prophylaxis after lung transplantation in patients who are CMV mismatch. The investigators will also look at the rates of negative side effects caused by antiviral prophylaxis in this population.

Conditions

Cytomegalovirus Infections

Study ID

NCT04439916

Start date

Jan 25, 2021

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • CMV seronegative recipients of CMV seropositive donor lung transplantation.
  • Age 18 years or older.
  • Receipt of antiviral prophylaxis with valganciclovir as per local protocol with a duration of 6 or 12 months after transplantation.
  • Monitoring of CMV DNAemia post-prophylaxis for at least 12 weeks as per local protocol.
  • Signed informed consent.

Exclusion Criteria:

  • Known allergy to ganciclovir or valganciclovir.
  • Neutropenia (< 1.0) pre-transplantation.
  • Living-donor lung transplantation.
  • Lung re-transplantation.
  • Pre-transplant immunodeficiency

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • CMV Breakthrough [ Time Frame: Up to 52 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

More Information

Sponsor

University of Alberta

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • CMV
  • Lung transplant
  • Valganciclovir

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-03-16.