Ongoing Clinical Trials for Lung Transplant Rejection
Currently, there is 1 ongoing clinical trial investigating new treatments for lung transplant rejection, specifically focusing on chronic lung allograft dysfunction (CLAD) that can occur after lung transplantation. This trial is being conducted across multiple European countries and is testing the effectiveness of belumosudil in combination with azithromycin for improving lung function in adults who have experienced chronic rejection after receiving a lung transplant.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Finland
- France
- Germany
- Hungary
- Italy
- Netherlands
- Norway
- Poland
- Spain
- Sweden
Study on the Effectiveness of Belumosudil and Azithromycin for Adults with Chronic Lung Rejection After Lung Transplant
This clinical trial focuses on chronic lung allograft dysfunction, commonly known as CLAD, a serious complication that can develop after someone receives a lung transplant. When the body’s immune system recognizes the transplanted lung as foreign, it can trigger an attack that leads to inflammation and damage to the lung tissue. Over time, this can significantly reduce lung function and breathing capacity.
Main focus and goal: The primary goal of this study is to evaluate whether belumosudil, taken as an oral tablet, can help improve lung function in adults with CLAD. The researchers want to determine if this medication can slow down the progression of chronic rejection and help maintain or improve patients’ ability to breathe. The study measures success by tracking forced expiratory volume in one second, which is a standard test that measures how much air a person can forcefully exhale in one second.
Investigational drug: The medication being tested is belumosudil, an immunosuppressant that works by inhibiting a specific enzyme involved in the immune response. By regulating immune system activity, it aims to reduce inflammation and prevent further rejection of the transplanted lung. Participants will also continue taking azithromycin, an antibiotic that has shown some benefit in managing CLAD.
Who can participate – Inclusion criteria:
- Adults who received a bilateral lung transplant at least one year before joining the study
- Diagnosed with CLAD Stage 1 or 2, meaning the condition is in its early stages
- Current lung function between 50% and 80% of their best performance after transplant
- Already taking azithromycin for at least 8 weeks before enrollment, at a dose of at least 250 mg per day, at least three times weekly
- Both men and women are eligible
Who cannot participate – Exclusion criteria:
- Patients who have not had both lungs transplanted
- Those whose CLAD is not classified as Stage 1 or 2
- Patients who fall outside the specified age range for the study
- Those who do not meet other specific clinical trial group requirements
How the study works: Participants are randomly assigned to receive either belumosudil or a placebo tablet that looks identical but contains no active medication. Neither the participants nor the researchers know who receives which treatment during the initial 26-week period. This double-blind approach helps ensure unbiased results. After this initial phase, all participants enter an open-label extension where everyone receives belumosudil, allowing for continued monitoring of lung function and overall health.
Throughout the study, participants attend regular check-ups where their lung function, exercise capacity, and quality of life are carefully monitored. The research team also watches for any side effects or health concerns to ensure participant safety. The study spans several months and provides valuable information about whether belumosudil can offer real benefits to people living with CLAD after lung transplantation.
Summary
This single ongoing trial represents an important effort to address chronic lung rejection following transplantation. The study’s breadth is notable, spanning 14 European countries including Poland, Italy, Finland, Belgium, Netherlands, Austria, Czechia, France, Spain, Denmark, Germany, Norway, Hungary, and Sweden. This wide geographic distribution suggests strong international collaboration and may help ensure diverse patient participation.
The trial focuses specifically on belumosudil as an investigational treatment for chronic lung allograft dysfunction, targeting patients in the early stages of this condition. The approach of combining belumosudil with azithromycin, which participants must already be taking, represents an effort to build upon existing treatment strategies rather than replace them entirely.
The study design is comprehensive, including both a blinded comparison phase and an open-label extension, which will provide valuable safety and efficacy data over an extended period. For patients living with chronic rejection after lung transplantation, this trial offers access to a novel treatment approach that may help preserve lung function and quality of life.
