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A Prospective Randomized Trial of ECP in Subclinical AMR

RecruitingNAAges 18 Years - anyAllMedical University of Vienna
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In plain words

What the trial is, and whether it could suit you

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. Th

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Bilateral lung transplantation * dnDSAs \> 3 months with a MFI \> 1000 * No signs of allograft dysfunction * Alemtuzumab induction therapy Exclusion Criteria: * Inclusion in other studies * Retransplantation * Multi-organ transplantation * \> 12 months after transplantation
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What it tests

  • Extracorporeal Photopheresis
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Where

7 sites
Medical University of Vienna
Vienna, Austria
UZ Leuven
Leuven, Belgium
University Hospital Center Zagreb
Zagreb, Croatia
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Hรดpital Foch
Suresnes, France
Policlinico San Matteo Pavia Fondazione IRCCS
Pavia, Italy
University Medical Centre Ljubljana
Ljubljana, Slovenia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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