A Prospective Randomized Trial of ECP in Subclinical AMR

NCT06112951 | Recruiting DMC

• 1 other identifier: 1578/2023
• Study Type: interventional
• Target: 80
• Locations: 7 countries
• Sites: 7

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. 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. 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?

Conditions

Antibody-mediated Rejection; Lung Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• Reduction of dnDSA titer from baseline MFI

  Difference of MFI values at the start and at the end of the six month period

  6 months

Secondary Outcomes (1)

• Incidence of clinical AMR, ACR, CLAD, survival, infectious complications, adverse effects

  6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Procedure: Extracorporeal Photopheresis

Control Group

NO INTERVENTION

Control group will be observed and no active treatment will be administered. This is our standard of care in the studied clinical situation.

Interventions

Extracorporeal Photopheresis PROCEDURE

Patients randomized into the interventional group will receive ECP. ECP will be started within one week after randomization. Initially 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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral lung transplantation
• dnDSAs \> 3 months with a MFI \> 1000
• No signs of allograft dysfunction
• Alemtuzumab induction therapy

You may not qualify if:

• Retransplantation
• Multi-organ transplantation
• \> 12 months after transplantation

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (7)

Medical University of Vienna

Vienna, 1090, 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

University Medical Centre Ljubljana

Ljubljana, Slovenia

NOT YET RECRUITING

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MeSH Terms

Interventions

Photopheresis

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Alberto Benazzo, MD PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Hillebrand, MD

CONTACT

+4314040069470; caroline.hillebrand@outlook.com

Alberto Benazzo, MD PhD

CONTACT

+4314040052600; alberto.benazzo@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv. Doz. Dr. Alberto Benazzo, PhD

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: November 2, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); FR (1); BE (1); CR (1); IT (1); AU (1); SL (1)