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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Andrew Fisher
+44 (0)191 2087067
a.j.fisher@ncl.ac.uk


Dr Newcastle Clinical Trials Unit
+44 (0)191 2082524
e-clad@newcastle.ac.uk


Dr Newcastle Clinical Trials Unit
+44 (0)191 2082524
e-clad@newcastle.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Extracorporeal Photopheresis (light treatment of white blood cells) in the treatment of Chronic Lung Allograft Dysfunction (chronic rejection): a randomised controlled trial
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Extracorporeal Photopheresis (light treatment of white blood cells) in the treatment of Chronic Lung Allograft Dysfunction (chronic rejection): a randomised controlled trial

Recruiting

Open to: All Genders

Age: Adult

Newcastle upon Tyne Cambridge Manchester Uxbridge Birmingham

Medical Conditions

Chronic lung allograft dysfunction

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Chronic lung allograft dysfunction (CLAD) is a complication that can happen after a lung transplant. CLAD develops when the immune system causes damage to the transplanted lungs, and lung function drops. It is also called chronic rejection. E-CLAD UK is a research study that aims to find out if a therapy called extracorporeal photopheresis (ECP) treatment can be used to treat CLAD. The research is being done by a team of specialists from all five UK adult lung transplant centres. ECP is currently used to treat various conditions involving the immune system. There have been a few small studies that suggest ECP could also help in the treatment of CLAD. However, there is currently not enough evidence for the NHS to say whether or not it should be used routinely to treat CLAD. The E-CLAD UK trial has been set up to answer this question.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

31 Jan 2023 30 Jun 2025

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38724453/ (added 10/05/2024)

The trial will involve 90 patients, who will all receive usual care for CLAD for 24 weeks. On top of that, half of these patients will also receive a course of ECP treatment. A course of ECP therapy involves 9 cycles of ECP treatment, every 2 weeks for 12 weeks and then 4 weekly until week 20. Each cycle involves 2 treatments, lasting between 2-3 hours on consecutive days. Both groups will continue all their routine clinic appointments with their transplant team.


Double lung or heart and double lung transplant recipients aged 16 years and over with a confirmed diagnosis of CLAD.

You can take part if:



You may not be able to take part if:


1. Single lung transplant recipients2. Female patients who are breastfeeding, pregnant or planning to become pregnant during the timeframe of study participation3. Current treatment with or past history of TLI completed within the last 12 months4. ≤1-month wash-out from any other investigational therapies for CLAD5. Inability to perform lung function tests or adhere to study protocol as judged by supervising clinician6. History of Hematopoietic Stem Cell Transplantation (HSCT)7. Patients who are on a retransplant waiting list8. Current participation in another interventional clinical trial, or participation in a clinical trial of an investigational agent in the previous 4 weeks from consent9. Patients with inadequate vascular access options to perform ECP10. Any contraindication to receiving ECP. These include: 10.1. Previous allergic reaction to Methoxsalen, another psoralen compound, or any of the other UVADEX® ingredients10.2. Co-existing untreated skin cancer (melanoma, basal cell or squamous cell cancer) if the patient deemed at higher risk of harm due to exposure to UVADEX or from their CLAD diagnosis10.3. Any disease which involves sensitivity to light such as porphyria, systemic lupus erythematosus or albinism10.4. Previous removal of spleen10.5. Blood clotting disorder or an increased white blood cell count >25 x 10e9 per litre10.6. Significant heart disease or severe anaemia causing inability to tolerate blood volume shifts associated with ECP10.7. Aphakia or lens removed from either eye (unless already blind in eye without a lens)10.8. Sexually active men and women of childbearing potential unless adequate contraception is used during treatment


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Freeman Road Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Royal Papworth Hospital
    Papworth Road Cambridge Biomedical Campus
    Cambridge
    CB2 0AY
  • Wythenshawe Hospital
    Southmoor Road Wythenshawe
    Manchester
    M23 9LT
  • Harefield Hospital
    Hill End Road Harefield
    Uxbridge
    UB9 6JH
  • Queen Elizabeth Hospital
    Mindelsohn Way
    Birmingham
    B15 2GW

The researchers can’t promise that taking part in this trial will benefit participants directly, although there is the possibility that the allocated treatments (either standard care or ECP) may help to treat CLAD. It is hoped that the information we get from this trial will help improve treatment for patients with CLAD in the future.
There are always risks with undergoing any trial procedure and all medical treatments can lead to side effects. The research team will monitor participants’ health regularly to ensure their wellbeing. The main known side effect of ECP is that it will temporarily make patients more sensitive to sunlight, meaning that they will have to take extra care of the sun for at least 24 hours after treatment. Other side effects can include tiredness, dizziness, feeling cold and a mildly raised temperature for a short time following treatment.

Prof Andrew Fisher
+44 (0)191 2087067
a.j.fisher@ncl.ac.uk


Dr Newcastle Clinical Trials Unit
+44 (0)191 2082524
e-clad@newcastle.ac.uk


Dr Newcastle Clinical Trials Unit
+44 (0)191 2082524
e-clad@newcastle.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Newcastle upon Tyne Hospitals NHS Foundation Trust and funded by Efficacy and Mechanism Evaluation Programme.



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Read full details for Trial ID: ISRCTN10615985

Or CPMS 53956

Last updated 10 May 2024

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