Status:
RECRUITING
A Prospective Randomized Trial of ECP in Subclinical AMR
Lead Sponsor:
Medical University of Vienna
Conditions:
Antibody-mediated Rejection
Lung Transplant Rejection
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
Detailed Description
Donor-specific antibodies (DSA) and antibody-mediated rejection have gained significant attention recently due to their serious consequences, but there are limited effective treatments for persistent ...
Eligibility Criteria
Inclusion
- Bilateral lung transplantation
- dnDSAs \> 3 months with a MFI \> 1000
- No signs of allograft dysfunction
- Alemtuzumab induction therapy
Exclusion
- Inclusion in other studies
- Retransplantation
- Multi-organ transplantation
- \> 12 months after transplantation
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06112951
Start Date
March 1 2024
End Date
June 1 2027
Last Update
July 9 2024
Active Locations (7)
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1
Medical University of Vienna
Vienna, Austria, 1090
2
UZ Leuven
Leuven, Belgium
3
University Hospital Center Zagreb
Zagreb, Croatia
4
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark