Evaluating extracorporeal photopheresis for subclinical lung transplant rejection
Official title: The Use of Extracorporeal Photopheresis as Immunomodulatory Therapy of Subclinical Antibody-mediated Rejection After Lung Transplantation: a Prospective RCT
Run by Medical University of Vienna · NCT06112951 · Data updated 2026-11-12
This study is testing if a light-based treatment called extracorporeal photopheresis can help lung transplant patients who have early signs of rejection feel better and improve their health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | Alemtuzumab |
| Locations | 7 sites (Vienna and 6 other locations) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | March 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | July 9, 2024 |
| Trial ID | NCT06112951 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients who have undergone bilateral lung transplantation and have persistent donor-specific antibodies with a mean fluorescence intensity greater than 1000.
✕Probably not a fit
Patients who have signs of allograft dysfunction or are more than 12 months post-transplant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the effectiveness of extracorporeal photopheresis (ECP) in patients with subclinical antibody-mediated rejection following lung transplantation. Participants will be randomized into two groups, with one receiving ECP treatment and the other serving as a control. The study will measure the reduction in donor-specific antibodies and evaluate various clinical outcomes, including acute cellular rejection, chronic lung allograft dysfunction, and overall survival. The trial seeks to provide insights into the immunological effects of ECP and its potential as a safe treatment option for this patient population.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for lung transplant recipients experiencing subclinical rejection.
How similar studies have gone: Previous studies have shown promise for extracorporeal photopheresis in treating antibody-mediated rejection, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Medical University of Vienna
Vienna, Austria Recruiting -
UZ Leuven
Leuven, Belgium Not yet recruiting -
University Hospital Center Zagreb
Zagreb, Croatia Not yet recruiting -
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark Not yet recruiting -
Hôpital Foch
Suresnes, France Not yet recruiting -
Policlinico San Matteo Pavia Fondazione IRCCS
Pavia, Italy Not yet recruiting
Show 1 more location
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University Medical Centre Ljubljana
Ljubljana, Slovenia Not yet recruiting
Study contacts
- Principal investigator: Alberto Benazzo, MD PhD — Medical University of Vienna
- Study coordinator: Caroline Hillebrand, MD
- Email: caroline.hillebrand@outlook.com
- Phone: +4314040069470
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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CID-103 for active and chronic active ABMR in kidney transplant patients
A two-part study will test CID-103, an anti-CD38 infusion, to see if it is safe and helps adults with active or chronic active antibody-mediated rejection after kidney transplant.
-
Hyperpolarized xenon-129 MRI signatures to detect and manage acute cellular rejection after lung transplant
We will see if hyperpolarized xenon-129 MRI can detect early acute cellular rejection in recent lung transplant recipients and guide targeted bronchoscopic sampling.
-
Comparing biopsy methods for lung transplant rejection diagnosis
This study tests which of two methods for taking lung tissue samples works better for diagnosing rejection in lung transplant patients.
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Research on improving outcomes for lung transplant donors and recipients
This study is trying to see how different donor and medical practices affect the health of lung transplant patients and donors, while also looking for blood markers that might predict complications after the surgery.
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Testing the effectiveness of belumosudil for treating lung transplant rejection
This study is testing if belumosudil can help improve lung function in adults who have had a lung transplant and are experiencing ongoing issues with their new lungs.
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Collecting blood samples from patients undergoing plasma exchange
This study is collecting blood samples from patients with immune-related diseases who are having plasma exchange to see how their antibody levels change during treatment and to use the samples for future research.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.