NCT06112951 A Prospective Randomized Trial of ECP in Subclinical AMR
| NCT ID | NCT06112951 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Antibody-mediated Rejection |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Alberto Benazzo, MD PhD
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT06112951 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Antibody-mediated Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06112951 currently recruiting?
Yes, NCT06112951 is actively recruiting participants. Contact the research team at caroline.hillebrand@outlook.com for enrollment information.
Where is the NCT06112951 trial being conducted?
This trial is being conducted at Vienna, Austria, Leuven, Belgium, Zagreb, Croatia, Copenhagen, Denmark and 3 additional locations.
Who is sponsoring the NCT06112951 clinical trial?
NCT06112951 is sponsored by Medical University of Vienna. The principal investigator is Alberto Benazzo, MD PhD at Medical University of Vienna. The trial plans to enroll 80 participants.