AzTrials
AzTrials

Lung Transplant RejectionNCT04792294

Multicenter Analysis of Efficacy and Outcomes of Extracorporeal Photopheresis as Treatment of Chronic Lung Allograft Dysfunction

An observational study of Lung Transplant Rejection, run by Medical University of Vienna.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Lung transplantation is an established therapy for end-stage lung disease such as chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis and pulmonary hypertension. However, Chronic Lung Allograft Dysfunction (CLAD) is a major cause of morbidity and mortality in long-term survivors. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lung Transplant Rejection
What is being tested?
Extracorporeal photopheresis
Type of treatment
Medical device
How many people
800 participants
Where
No sites listed yet
Study dates
1 Jan 2005to 31 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Lung transplant recipients with chronic lung allograft dysfunction who received extracorporeal photopheresis as treatment

Who may be able to join

  • Diagnosis of CLAD Adult transplant recipients (>18 years)

Who cannot join

  • ECP for other diagnosis Recipients of multi-organ transplantation Recipients of single lung transplantation

About this study

Lung transplantation is an established therapy for end-stage lung disease such as chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis and pulmonary hypertension. However, Chronic Lung Allograft Dysfunction (CLAD) is a major cause of morbidity and mortality in long-term survivors. The 5-year survival rate is reported to be 50%, which is considerably inferior compared to other solid organ transplantation. In addition, the financial burden of CLAD (around 80.000 euro/year for a patient with CLAD) is considerable. No curative therapy is available yet. To date, the two most effective treatment are azithromycin and extracorporeal photopheresis. Azithromycin is used as first-line treatment and it is effective in stopping FEV1 decline, however its effects are only limited to a set of patients. ECP can be used as second-line treatment in patients unresponsive to azithromycin. ECP has been firstly developed for treatment of cutaneous T cell lymphomas and later used in a variety of other indications including solid organ transplantation. The process starts with leukapheresis, followed by incubation of the isolated cells with 8-methoxypsoralen (8-MOP) and subsequent activation of 8-MOP with ultraviolet A radiation. At the end, the cells are reinfused into the patient. 8-MOP is a biologically inert substance, but in the presence of UVA light it cross-links DNA by forming covalent bonds with pyrimidine bases and causes apoptosis. ECP is effective in the palliative treatment of cutaneous T-cell lymphoma but its effectiveness was also shown in several other T-cell-mediated diseases, particularly in the treatment and prevention of acute and chronic graft-versus-host disease. In depth knowledge on the mechanisms whereby ECP manipulates the immune system are still unclear. Most of the experimental studies have been performed in murine models of GvHD. Apoptotic cells isolated during ECP treatment have the potential to induce IL-10 secretion, reduce dendritic cells activation and increase percentage of Tregs. In addition, ECP reduces the production of IL-6 and TNF-α and increases TGF-β production. In lung transplantation, ECP treatment is used as second-line treatment of CLAD and it has the potential to stabilize lung function decline and to improve long-term graft. According to the published literature, however, approximately 30 to 40% of treated recipients did not profit from ECP. Greer and colleagues found that RAS patients as well as rapid lung function decliners showed lower rate of response and worse long-term outcomes. On the contrary in a more recent analysis only BOS diagnosis was associated with better outcomes. A single prospective interventional study was published by our group and it confirmed results from other previous retrospective analysis. Up to now, no clear predictors for response have been identified yet.

Being tested
Extracorporeal photopheresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extracorporeal photopheresisDevice

    ECP can be used as second-line treatment in patients unresponsive to azithromycin. ECP has been firstly developed for treatment of cutaneous T cell lymphomas and later used in a variety of other indications including solid organ transplantation. The process starts with leukapheresis, followed by incubation of the isolated cells with 8-methoxypsoralen (8-MOP) and subsequent activation of 8-MOP with ultraviolet A radiation. At the end, the cells are reinfused into the patient. 8-MOP is a biologically inert substance, but in the presence of UVA light it cross-links DNA by forming covalent bonds with pyrimidine bases and causes apoptosis.

Study groups in NCT04792294
Study groupRoleWhat they receive
Lung transplant recipients with chronic lung allograft dysfunctionLung transplant recipients with chronic lung allograft dysfunction, who underwent extracorporeal photopheresis
Receives: Device: Extracorporeal photopheresis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in forced expiratory value in 1 second at 3 months after start of extracorporeal photopheresis

    Percentage change in FEV1 within 3 months after start of extracorporeal photopheresis

    Measured: 3 months

Secondary outcomes (6)
  1. change in maximal expiratory flow (50%) at 3 months after start of extracorporeal photopheresis

    Percentage change in MEF50 within 3 months after start of extracorporeal photopheresis

    Measured: 3 months

  2. Change in forced expiratory value in 1 second/dorced vital capacity ratio at 3 months after start of extracorporeal photopheresis

    Percentage change in FEV1/FVC within 3 months after start of extracorporeal photopheresis

    Measured: 3 months

  3. Change in total lung capacity at 3 months after start of extracorporeal photopheresis

    Percentage change in TLC within 3 months after start of extracorporeal photopheresis

    Measured: 3 months

  4. Patients' survival

    Patients' survival

    Measured: Within 5 years from start of extracorporeal photopheresis

  5. Graft survival

    Graft survival

    Measured: Within 5 years from start of extracorporeal photopheresis

  6. Adverse events on extracorporeal photopheresis

    Adverse events on extracorporeal photopheresis

    Measured: Within 5 years from start of extracorporeal photopheresis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start1 Jan 2005
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792294
Sponsor's protocol ID
1541/2020
Status last verified
Mar 2021
First submitted
25 Feb 2021
Last updated
10 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Transplant Rejection, run by Medical University of Vienna.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in forced expiratory value in 1 second at 3 months after start of extracorporeal photopheresis (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in