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Lung Transplant clinical trials at UCSF
6 in progress, 2 open to new patients

  • Cromolyn Detection of Silent Aspiration

    open to eligible people ages 18–70

    The overall purpose of this project is to develop and validate a simple, non-invasive method to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration.

    San Francisco, California

  • International EXPAND Lung Pivotal Trial

    open to eligible people ages 18–75

    To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

    San Francisco, California and other locations

  • Comparison of Coronary CT Angiography With Conventional Coronary Angiography in Liver and Lung Transplant Candidates

    Sorry, currently not accepting new patients, but might later

    The overall goal of this study is to determine if non-invasive imaging with state of the art CT coronary angiography can be used to screen for coronary artery disease in high risk patients prior to liver and lung transplantation. The current protocol for coronary artery disease assessment at UCSF before liver and lung transplantation involves screening with stress tests and/or coronary angiograms in patients with increased risk of coronary artery disease. Coronary angiogram will be used as gold standard for assessment of coronary CTA accuracy.

    San Francisco, California

  • Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction

    Sorry, not yet accepting patients

    Despite advances in lung transplantation, the median survival remains only 55% at 5 years. The main limitation to long term survival is the development of chronic lung allograft dysfunction. In approximately 30% of cases, chronic lung allograft dysfunction has a restrictive phenotype (RCLAD) characterized by fibrosis with rapid progression to respiratory failure. Approximately 60% of patients with RCLAD die within one year, as currently there are no therapies available. RCLAD, like Idiopathic Pulmonary Fibrosis (IPF), is characterized by fibroblast proliferation, extracellular matrix deposition, and architectural distortion leading to progressive lung scarring and death. Given their similarities, there is keen interest in the international transplant community to investigate whether the anti-fibrotic drug pirfenidone can slow the progression of RCLAD as it does of IPF. Pirfenidone has been proved to be safe and effective in patients with IPF, and is approved by the Food and Drug Administration. This protocol will evaluate the safety and tolerability of pirfenidone in lung transplant recipients with RCLAD. Transplant recipients take carefully adjusted immunosuppressive medications for life to prevent rejection of the allograft. Current literature suggests the dose of tacrolimus, the main anti-rejection drug, may need to be adjusted when taken in combination with pirfenidone. The investigators will assess the side effects of pirfenidone in combination with the immunosuppressive regimen and determine the magnitude of the adjustment in tacrolimus dose. The results of this pilot study will provide the foundation for a multicenter randomized control trial to evaluate the efficacy of pirfenidone in slowing the progression of RCLAD.

  • Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation

    Sorry, not yet accepting patients

    To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

    San Francisco, California and other locations

  • Tacrolimus Adjustment by NFAT-related Gene Expression in Lung Allograft Recipients.

    Sorry, in progress, not accepting new patients

    This is a non-interventional cohort study to assess a novel assay to detect excessive or insufficient immunosuppression from the drug tacrolimus in lung transplant recipients. The assay measures mean residual expression (MRE) of genes downstream of NFAT, a transcription factor regulated by tacrolimus. The investigators will assess whether MRE levels identify subjects at risk for rejection (insufficient immunosuppression) or infection (excessive immunosuppression).

    San Francisco, California