A Prospective Randomized Trial of ECP in Subclinical AMR

Launched by MEDICAL UNIVERSITY OF VIENNA · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called extracorporeal photopheresis (ECP) for patients who have had a lung transplant and are showing early signs of antibody-mediated rejection, which is when the body’s immune system starts to attack the new lung. The researchers want to find out if ECP can help reduce the level of certain antibodies in the blood and improve overall health outcomes for these patients, such as reducing the risk of further rejection or infections.

To participate, patients must have received a lung transplant at least three months ago, show specific antibody levels, and have no signs of lung dysfunction. Participants will be randomly divided into two groups: one group will receive ECP treatment every two weeks for the first two months and then once a month for the next six months, while the other group will not receive any active treatment but will be closely monitored. This trial is currently recruiting participants aged 65 to 74, regardless of gender. If you or a loved one are considering joining, it’s a good opportunity to potentially benefit from a new treatment while helping researchers learn more about managing lung transplant health.

Gender

ALL

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