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Study identifier: NCT06112951 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Prospective Randomized Trial of ECP in Subclinical AMR

Condition: Antibody-mediated Rejection · Lung Transplant Rejection  ·  Sponsor: Medical University of Vienna

PhaseNA
Planned participants80
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Caroline Hillebrand, MD  ·  +4314040069470  ·  caroline.hillebrand@outlook.com

Alberto Benazzo, MD PhD  ·  +4314040052600  ·  alberto.benazzo@meduniwien.ac.at

Always discuss trial participation with your own doctor first.

Locations (7)

Medical University of ViennaVienna, AustriaRecruiting
UZ LeuvenLeuven, BelgiumNot Yet Recruiting
University Hospital Center ZagrebZagreb, CroatiaNot Yet Recruiting
Copenhagen University Hospital, RigshospitaletCopenhagen, DenmarkNot Yet Recruiting
Hôpital FochSuresnes, FranceNot Yet Recruiting
Policlinico San Matteo Pavia Fondazione IRCCSPavia, ItalyNot Yet Recruiting
University Medical Centre LjubljanaLjubljana, SloveniaNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06112951