Extracorporeal Photopheresis (ECP) After Lung Transplantation

January 31, 2023 updated by: Peter Jaksch, Priv.Doz. Dr., Medical University of Vienna

Prophylactic Use of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The intention of the planned study is the use of ECP as a form of induction treatment in combination with standard immunosuppressive therapy (IST). Two randomized cohorts (each group 31 patients), all pats with COPD, will be investigated - group A ECP with standard triple IST vs group B just with IST.

Endpoints are the incidence of acute rejection episodes (about 30-40% incidence within the first year) and the development of early chronic allograft dysfunction (CLAD). Further parameters to be investigated are the number of CMV-infectious complications.

Parallel to the clinical parameters and investigation of immunologic test 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 analysed to compare the influence of ECP vs standard IST on these parameters.

How ECP is working is still a pending question but it seems to modulate the immune response maybe via influencing Tregs and apoptosis of upregulated T lymphocytes.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ECP with standard triple IST
Device: ECP (Extracorporeal Photopheresis System)
After the cells have been inoculated with UVADE, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and the infused back into the patient.
Other Names:
  • 8-Methoxypsoralen extracopraeal
ACTIVE_COMPARATOR: standard triple IST
Device: ECP (Extracorporeal Photopheresis System)
After the cells have been inoculated with UVADE, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and the infused back into the patient.
Other Names:
  • 8-Methoxypsoralen extracopraeal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute cellular rejection
Time Frame: 12 months
patients with acute rejection, biopsy proven with ISHLT grade > 1 histology
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ESTIMATE)

February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECP-LUTX V 3.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To evaluate the safety and efficacy of ECP in addition to a standard triple immunosuppressive therapy consisting of Tacrolimus (Tac), Mycophenolate Mofetile (MMF) and corticosteroids for prevention of episodes of acute rejection in lung transplant recipients.

IPD Sharing Time Frame

within the next 6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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