A Prospective Randomized Trial of ECP in Subclinical AMR
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 baseli
| Condition(s) | Antibody-mediated Rejection, Lung Transplant Rejection |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. Firs |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Medical University of Vienna |
| Locations | Vienna, Austria; Leuven, Belgium; Zagreb, Croatia; Copenhagen, Denmark; Suresnes, France; Pavia, Italy (+1 more sites) |
| Start date | 2024-03-01 |
| NCT ID | NCT06112951 |
| Official listing | https://clinicaltrials.gov/study/NCT06112951 |