A Prospective Randomized Trial of ECP in Subclinical AMR

ConditionsAntibody-mediated Rejection Lung Transplant Rejection

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMedical University of Vienna

About this trial

The goal of this clinical trial is to evaluate the therapeutic effect of extracorporeal photopheresis in subclinical antibody-mediated rejection after lung transplantation.The main questions it aims to answer are:

1. Does ECP therapy result in a significant reduction in MFI (Mean Fluorescence Intensity) from the baseline MFI in clinically stable patients with persistent (\>6 months) dnDSAs (MFI\>1000)? 2. What is the impact of ECP therapy on the following outcomes in these patients: ACR, clinical AMR, CLAD, infections, drop-out rate, survival, adverse events?

Participants will be randomized into two groups. Each group will include 40 patients. The control group will be observed and no active treatment will be administered. The treatment group will receive extracorporeal photopheresis. First, a two-day treatment cycle will be performed once every second week for the first two months. Then, a two-day treatment cycle will be performed once a month for 6 months.

Researchers will compare the two groups regarding: MFI value, development of ACR, clinical AMR, CLAD, infections, survival, adverse events, immunophenotyping, miRNA expression profiling, cytokine expression, gene expression signature of PBMCs and proteomic characterization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Bilateral lung transplantation

dnDSAs > 3 months with a MFI > 1000

No signs of allograft dysfunction

Alemtuzumab induction therapy

Disqualifiers

Inclusion in other studies

Retransplantation

Multi-organ transplantation

> 12 months after transplantation

Trial design

Design model

Parallel

Treatments tested in this trial

Extracorporeal Photopheresis
Procedure/Surgery
Patients randomized into the interventional group will receive ECP. ECP will be started within one week after randomization. Initially a two-day treatment cycle will be performed once every second week for the first two months. Then, a two-day treatment cycle will be performed once a month for 6 months.