Lung Transplant InfectionNCT05721079
Extracorporeal Photopheresis (ECP) After Lung Transplantation
A study testing ECP (Extracorporeal Photopheresis System) in people with Lung Transplant Infection and Lung Transplant Rejection, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to investigate the use of ECP for lung-transplanted patients to reduce the occurrence of acute and chronic rejection and CMV-infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Infection, Lung Transplant Rejection
- What is being tested?
- ECP (Extracorporeal Photopheresis System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2017to 31 Dec 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing first lung transplantation
- Patient underlying disease COPD
- Male or female be 18 years or older
- Patients (male and female) must agree to use an acceptable method of birth control the treatment period of 3 months and 3 months afterward
- Patients must have a body weight more than 40 kg
- Patients must have a platelet count more than 20.000/cmm
- Patients must be willing and capable of understanding the purpose and risks of the study and must sign a statement of informed consent
Who cannot join
- Previous organ transplantation
- Women who are pregnant and/or lactating
- Patients with hypersensitivity or allergy to both heparin and citrate products
- Patients who are unable to tolerate extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, renal failure or hepatic failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Use of Extracorporeal Photopheresis (ECP) After Lung Transplantation
The purpose of this study is to investigate the use of ECP for lung-transplanted patients to reduce the occurrence of acute and chronic rejection and CMV-infection.
Read the detailed description
The intention of the planned study is the use of ECP as a form of induction treatment in combination with standard triple-drug immunosuppressive therapy (IS). This is a single-center prospective randomized controlled trial conducted at Medical University of Vienna between 2018 and 2020. It includes 31 COPD recipients per group. Treatment group underwent ECP with in addition to IS after lung transplantation. Control group received only IS. The primary outcome was a composite outcome defined as incidence of high-grade ACR, CMV infection or CLAD within 24 months after lung transplantation.
Parallel to the clinical parameters, immunologic investigations will be performed to get a better insight into the mechanisms of ECP on the immune system. The dynamics of Tregs and dentritic cell will be analyzed to compare the influence of ECP vs standard IS.
- Being tested
- ECP (Extracorporeal Photopheresis System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECP (Extracorporeal Photopheresis System)Device
Also called 8-Methoxypsoralen
Patients who are assigned to the ECP group receive treatments by means of the THERAKOS ® CELLEX ® Photopheresis System (Mallinckrodt Pharmaceuticals Inc.) with either double- or single-needle access. During the leukapheretic processing, 1500 ml of whole blood is processed, and peripheral blood mononuclear cells (MCNs) are separated by centrifugation and collected in the buffy coat. 8-methoxypsoralen (Uvadex®, Mallinckrodt Pharmaceuticals Inc.) at a dose of 20 μg/ml is added to the MNC collection bag and cells are irradiated with ultraviolet A light (1.5 J/cm2) in a 1-mm-thick film through a photoactivation plate. After exposure of the cells to the ultraviolet light, the buffy coat is reinfused into the patient.
| Study group | Role | What they receive |
|---|---|---|
| ECP with standard triple IS | Experimental | Not described Receives: Device: ECP (Extracorporeal Photopheresis System) |
| standard triple IS | Active comparator | Not described Receives: Device: ECP (Extracorporeal Photopheresis System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint
the incidence of high-grade ACR, cytomegalovirus (CMV) infection or CLAD
Measured: 24 months
Secondary outcomes (8)
Frequency of ACR and of lymphocytic bronchiolitis (LB)
Frequency of ACR and of lymphocytic bronchiolitis (LB)
Measured: 24 months
Incidence of clinically treated infections
Incidence of clinically treated infections
Measured: 24 months
Detection of plasma CMV DNA
Detection of plasma CMV DNA
Measured: 24 months
Patient survival
Patient survival
Measured: 36 months
Graft survival
Graft survival
Measured: 36 months
Incidence of de-novo donor specific antibodies
Incidence of de-novo donor specific antibodies
Measured: 24 months
Number of AMR episodes
Number of AMR episodes
Measured: 24 months
Incidence of CLAD
Incidence of CLAD
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Mar 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant InfectionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Jaksch, Priv.Doz. Dr., Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721079
- Sponsor's protocol ID
- ECP-LUTX V 3.0
- Status last verified
- Aug 2024
- First submitted
- 31 Jan 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To evaluate the safety and efficacy of ECP in addition to a standard triple immunosuppressive therapy consisting of Tacrolimus (Tac), Mycophenolate Mofetile (MMF) and corticosteroids to prevent rejection and infections.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Extracorporeal Photopheresis (ECP) After Lung Transplantation
- ClinicalTrials.gov ID
- NCT05721079
- Acronym / sponsor ID
- ECP-LUTX V 3.0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the use of ECP for lung-transplanted patients to reduce the occurrence of acute and chronic rejection and CMV-infection.
Detailed description
The intention of the planned study is the use of ECP as a form of induction treatment in combination with standard triple-drug immunosuppressive therapy (IS). This is a single-center prospective randomized controlled trial conducted at Medical University of Vienna between 2018 and 2020. It includes 31 COPD recipients per group. Treatment group underwent ECP with in addition to IS after lung transplantation. Control group received only IS. The primary outcome was a composite outcome defined as incidence of high-grade ACR, CMV infection or CLAD within 24 months after lung transplantation.
Parallel to the clinical parameters, immunologic investigations will be performed to get a better insight into the mechanisms of ECP on the immune system. The dynamics of Tregs and dentritic cell will be analyzed to compare the influence of ECP vs standard IS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECP with standard triple IS | Experimental | Device: ECP (Extracorporeal Photopheresis System) |
| standard triple IS | Active comparator | Device: ECP (Extracorporeal Photopheresis System) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients undergoing first lung transplantation
- Patient underlying disease COPD
- Male or female be 18 years or older
- Patients (male and female) must agree to use an acceptable method of birth control the treatment period of 3 months and 3 months afterward
- Patients must have a body weight more than 40 kg
Key exclusion criteria (4 listed)
- Previous organ transplantation
- Women who are pregnant and/or lactating
- Patients with hypersensitivity or allergy to both heparin and citrate products
- Patients who are unable to tolerate extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, renal failure or hepatic failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECP (Extracorporeal Photopheresis System)Also: 8-MethoxypsoralenPatients who are assigned to the ECP group receive treatments by means of the THERAKOS ® CELLEX ® Photopheresis System (Mallinckrodt Pharmaceuticals Inc.) with either double- or single-needle access. During the leukapheretic processing, 1500 ml of whole blood is processed, and peripheral blood mononuclear cells (MCNs) are separated by centrifugation and collected in the buffy coat. 8-methoxypsoralen (Uvadex®, Mallinckrodt Pharmaceuticals Inc.) at a dose of 20 μg/ml is added to the MNC collection bag and cells are irradiated with ultraviolet A light (1.5 J/cm2) in a 1-mm-thick film through a photoactivation plate. After exposure of the cells to the ultraviolet light, the buffy coat is reinfused into the patient. | Device | ECP with standard triple IS, standard triple IS |
Primary outcome
Composite endpoint
Time frame: 24 months
the incidence of high-grade ACR, cytomegalovirus (CMV) infection or CLAD
8 secondary outcomes
Frequency of ACR and of lymphocytic bronchiolitis (LB)
Time frame: 24 months
Incidence of clinically treated infections
Time frame: 24 months
Detection of plasma CMV DNA
Time frame: 24 months
Patient survival
Time frame: 36 months
Graft survival
Time frame: 36 months
Incidence of de-novo donor specific antibodies
Time frame: 24 months
Number of AMR episodes
Time frame: 24 months
Incidence of CLAD
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Yes. To evaluate the safety and efficacy of ECP in addition to a standard triple immunosuppressive therapy consisting of Tacrolimus (Tac), Mycophenolate Mofetile (MMF) and corticosteroids to prevent rejection and infections.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECP (Extracorporeal Photopheresis System) in people with Lung Transplant Infection and Lung Transplant Rejection, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite endpoint (time frame: 24 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 23 Aug 2024.