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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Bilateral lung transplantation

• dnDSAs \> 3 months with a MFI \> 1000

• No signs of allograft dysfunction

• Alemtuzumab induction therapy

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Belgium
UZ Leuven
NOT_YET_RECRUITING
Leuven
Croatia
University Hospital Center Zagreb
NOT_YET_RECRUITING
Zagreb
Denmark
Copenhagen University Hospital, Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
France
Hôpital Foch
NOT_YET_RECRUITING
Suresnes
Italy
Policlinico San Matteo Pavia Fondazione IRCCS
NOT_YET_RECRUITING
Pavia
Slovenia
University Medical Centre Ljubljana
NOT_YET_RECRUITING
Ljubljana
Contact Information
Primary
Caroline Hillebrand, MD
caroline.hillebrand@outlook.com
+4314040069470
Backup
Alberto Benazzo, MD PhD
alberto.benazzo@meduniwien.ac.at
+4314040052600
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 80
Treatments
Experimental: Treatment Group
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.
No_intervention: Control Group
Control group will be observed and no active treatment will be administered. This is our standard of care in the studied clinical situation.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov