The purpose of this study is to assess the efficacy and safety of the study drug, known as "ATG Fresenius S," which is sometimes called "EZ-2053," to prevent a lung transplant patient's body from rejecting a transplanted lung or lungs.
Patients are generally consented for the study once they go on the lung transplant waiting list and then are re-consented periodically thereafter until they undergo the lung transplant surgery. A pre-surgical assessment consisting of medical history, physical exam, ECG, chest X-Ray, and blood tests are conducted. After lung transplant surgery, patients are assessed for continued eligibility. Within 6-24 hours after the end of surgery, patients are randomized to receive one infusion of study drug or placebo through a central venous catheter. Each day for 5 days following transplant surgery, patients are monitored for transplant rejection, infections, adverse events and laboratory test changes. On post-randomization Days 14, 30, 60, 90, 180, 270 and 365, patients will be monitored for acute transplant rejection, infections and cancer, pulmonary function tests and adverse experiences. Pulmonary biopsies will be performed on post-randomization Days 30, 60, 90, 180 and 365. Blood samples will be drawn during each visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
223
placebo infusion, single
single IV infusion, 9 mg/kg
single IV infusion, 5mg/kg
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)
Time frame: 12 months
Number of Participants With Death or Graft Loss Post-transplant
Time frame: 12 months
Number of Participants With Acute Rejection
Time frame: 12 months
Number of Participants With Infections and Infestations
Time frame: 12 months
Number of Participants With Severe Adverse Events
Time frame: 12 months
Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test
Time frame: 12 months
Pulmonary Function Test, Forced Vital Capacity
Time frame: 12 months
Pulmonary Function Test, Forced Expiratory Volume in 1 Second
Time frame: 12 months
Pulmonary Function Test, Forced Expiratory Flow 25-75
Time frame: 12 months
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