RecruitingNot ApplicableNCT06112951

A Prospective Randomized Trial of ECP in Subclinical AMR

The Use of Extracorporeal Photopheresis as Immunomodulatory Therapy of Subclinical Antibody-mediated Rejection After Lung Transplantation: a Prospective RCT


Sponsor

Medical University of Vienna

Enrollment

80 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria4

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

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Interventions

PROCEDUREExtracorporeal Photopheresis

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.


Locations(7)

Medical University of Vienna

Vienna, Austria

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

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NCT06112951


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