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Completed

NCT Number: NCT05721079

Extracorporeal Photopheresis (ECP) After Lung Transplantation

The purpose of this study is to investigate the use of ECP for lung-transplanted patients to reduce the occurrence of acute and chronic rejection and CMV-infection.

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Key information

Conditions

Lung Transplant Infection Lung Transplant Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Vienna

Vienna, 1090, Austria

About this study

The intention of the planned study is the use of ECP as a form of induction treatment in combination with standard triple-drug immunosuppressive therapy (IS). This is a single-center prospective randomized controlled trial conducted at Medical University of Vienna between 2018 and 2020. It includes 31 COPD recipients per group. Treatment group underwent ECP with in addition to IS after lung transplantation. Control group received only IS. The primary outcome was a composite outcome defined as incidence of high-grade ACR, CMV infection or CLAD within 24 months after lung transplantation.

Parallel to the clinical parameters, immunologic investigations will be performed to get a better insight into the mechanisms of ECP on the immune system. The dynamics of Tregs and dentritic cell will be analyzed to compare the influence of ECP vs standard IS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing first lung transplantation
  • Patient underlying disease COPD
  • Male or female be 18 years or older
  • Patients (male and female) must agree to use an acceptable method of birth control the treatment period of 3 months and 3 months afterward
  • Patients must have a body weight more than 40 kg
  • Patients must have a platelet count more than 20.000/cmm
  • Patients must be willing and capable of understanding the purpose and risks of the study and must sign a statement of informed consent

Exclusion criteria

  • Previous organ transplantation
  • Women who are pregnant and/or lactating
  • Patients with hypersensitivity or allergy to both heparin and citrate products
  • Patients who are unable to tolerate extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, renal failure or hepatic failure

Treatment and study plan

ECP (Extracorporeal Photopheresis System)

Device

Patients who are assigned to the ECP group receive treatments by means of the THERAKOS ® CELLEX ® Photopheresis System (Mallinckrodt Pharmaceuticals Inc.) with either double- or single-needle access. During the leukapheretic processing, 1500 ml of whole blood is processed, and peripheral blood mononuclear cells (MCNs) are separated by centrifugation and collected in the buffy coat. 8-methoxypsoralen (Uvadex®, Mallinckrodt Pharmaceuticals Inc.) at a dose of 20 μg/ml is added to the MNC collection bag and cells are irradiated with ultraviolet A light (1.5 J/cm2) in a 1-mm-thick film through a photoactivation plate. After exposure of the cells to the ultraviolet light, the buffy coat is reinfused into the patient.

Other names: 8-Methoxypsoralen

Primary outcomes

  1. Composite endpoint

    Time frame: 24 months

    the incidence of high-grade ACR, cytomegalovirus (CMV) infection or CLAD

Secondary outcomes

  1. Frequency of ACR and of lymphocytic bronchiolitis (LB)

    Time frame: 24 months

    Frequency of ACR and of lymphocytic bronchiolitis (LB)

  2. Incidence of clinically treated infections

    Time frame: 24 months

    Incidence of clinically treated infections

  3. Detection of plasma CMV DNA

    Time frame: 24 months

    Detection of plasma CMV DNA

  4. Patient survival

    Time frame: 36 months

    Patient survival

  5. Graft survival

    Time frame: 36 months

    Graft survival

  6. Incidence of de-novo donor specific antibodies

    Time frame: 24 months

    Incidence of de-novo donor specific antibodies

  7. Number of AMR episodes

    Time frame: 24 months

    Number of AMR episodes

  8. Incidence of CLAD

    Time frame: 36 months

    Incidence of CLAD

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Prophylactic Use of Extracorporeal Photopheresis (ECP) After Lung Transplantation

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2023
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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