Actively Recruiting
A Prospective Randomized Trial of ECP in Subclinical AMR
Led by Medical University of Vienna · Updated on 2024-07-09
80
Participants Needed
7
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Randomized Trial of ECP in Subclinical AMR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bilateral lung transplantation
- Presence of donor-specific antibodies (dnDSAs) for more than 3 months with MFI greater than 1000
- No signs of graft dysfunction
- Received alemtuzumab induction therapy
You will not qualify if you...
- Participation in other studies
- History of retransplantation
- Undergoing multi-organ transplantation
- More than 12 months since transplantation
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Trial Site Locations
Total: 7 locations
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
2
UZ Leuven
Leuven, Belgium
Not Yet Recruiting
3
University Hospital Center Zagreb
Zagreb, Croatia
Not Yet Recruiting
4
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Not Yet Recruiting
5
Hôpital Foch
Suresnes, France
Not Yet Recruiting
6
Policlinico San Matteo Pavia Fondazione IRCCS
Pavia, Italy
Not Yet Recruiting
7
University Medical Centre Ljubljana
Ljubljana, Slovenia
Not Yet Recruiting
Research Team
C
Caroline Hillebrand, MD
CONTACT
A
Alberto Benazzo, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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