Lung Transplant
Conditions
Keywords
ALAD, Acute Lung Allograft Dysfunction, Lung Transplant
Brief summary
This study is testing a medication called emapalumab to see if it can help people who have had a lung transplant and are experiencing a sudden drop in lung function, called acute lung allograft dysfunction (ALAD). ALAD is a serious condition that can happen after a lung transplant and can lead to worsening breathing and other complications. Right now, there is no approved treatment for ALAD. The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days.
Detailed description
You may be able to join if: You had a lung transplant more than 10 months ago, and Your lung function has dropped by 10% or more compared to your best level in the past 6 months. What will happen in the study? As part of your usual care, you will have a procedure called a bronchoscopy (a test that looks inside your lungs). During this test, doctors will collect samples to check for infection and measure certain markers in your lungs and blood. These results will help determine if you can join the study. People with certain lung infections will not be able to participate. Study treatment The study has two parts: Part 1 (finding the right dose): Small groups of participants will receive different doses of emapalumab through an IV (into a vein). The goal is to find the dose that best blocks harmful inflammation in the lungs. Part 2 (testing how well it works): Participants will receive the selected dose of emapalumab. Doctors will: Monitor blood and lung markers, Check for viruses, Follow your progress weekly for about 4 weeks. Study goals: The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days. The study will also look at: Whether the condition gets worse or improves, How safe the treatment is, Overall outcomes after treatment.
Interventions
DRUGEmapalumab
This is a one-time infusion
DRUGPlacebo
This is a one-time infusion of inactive drug
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a multi-center, prospective, biomarker-driven, placebo-controlled, randomized interventional study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recipients ≥10 months post-lung transplant who are enrolled in existing biorepository study (IRB #13-10738) will be approached if they have ALAD and elevated AI2 and CXCL9 levels * Age: ≥18 years old * Informed Consent: Ability to provide written informed consent to participate in the study.
Exclusion criteria
* Active Bacterial Infection: Positive bacterial cultures from bronchoalveolar lavage (BAL) samples at the time of ALAD diagnosis. Viral infections, which are typically treated in lung transplant recipients with a steroid taper and cleared by type I interferons, are not
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery from Acute Lung Allograft Dysfunction, defined by International Society for Heart and Lung Transplantation guidelines as a return to within 10% of baseline FEV1 within 90 days | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| CXCL9 area under the curve (AUC), safety outcomes and retransplant-free survival will be used to measure ALAD Progression | 90 days |
Countries
United States
Contacts
CONTACTLegna Betancourt
CONTACTPrincipal Investigator
PRINCIPAL_INVESTIGATORJohn Greenland, Dr.
University of California, San Francisco
PRINCIPAL_INVESTIGATORJohn Belperio, Dr.
University of California, Los Angeles
Outcome results
None listed