A Prospective Randomized Trial of ECP in Subclinical AMR

Recruiting now · Not applicable

Conditions studied: Antibody-mediated Rejection, Lung Transplant Rejection

In brief

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.

Key facts

Study ID

NCT06112951

Run by

Medical University of Vienna

People needed

80

Starts

2024-03-01

Expected to finish

2027-06-01

Last updated by the study team

2024-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Bilateral lung transplantation
• dnDSAs > 3 months with a MFI > 1000
• No signs of allograft dysfunction
• Alemtuzumab induction therapy

You may not qualify if…

• Inclusion in other studies
• Retransplantation
• Multi-organ transplantation
• > 12 months after transplantation

Where it is running

• Medical University of Vienna — Vienna, Austria (enrolling)
• UZ Leuven — Leuven, Belgium
• University Hospital Center Zagreb — Zagreb, Croatia
• Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark
• Hôpital Foch — Suresnes, France
• Policlinico San Matteo Pavia Fondazione IRCCS — Pavia, Italy
• University Medical Centre Ljubljana — Ljubljana, Slovenia

Full record on ClinicalTrials.gov

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