EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
Condition: Chronic Obstructive Pulmonary; Idiopathic Pulmonary Fibrosis; Cystic Fibrosis; Bronchiectasis; Pulmonary Vascular Disease
MeSH terms: Cystic Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Bronchiectasis; Vascular Diseases; Fibrosis
Intervention: Placebo; EZ-2053; EZ-2053 5mg/kg
Intervention description: placebo infusion, single; single IV infusion, 9 mg/kg; single IV infusion, 5mg/kg
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G; Antilymphocyte Serum
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pulmonary transplantation; Pulmonary Allograft Rejection

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient of a primary single or double pulmonary allograft

          -  Capable of understanding the purposes and risks of the study and has given written
             informed consent, and agrees to comply with the study requirements

          -  Women of childbearing potential must have a negative serum pregnancy test within 4
             days prior to randomization.

        Exclusion Criteria:

          -  Undergoing second or living donor transplant

          -  Prior treatment with T-cell depleting agents within the previous 5 years for the
             purpose of immunosuppression

          -  Prior plasma exchange and/or treatment with IVIg within the past 5 years

          -  Pulmonary infection with pan-resistant Pseudomonas or any Burkholderia species

          -  Known positive blood cultures

          -  Donor lung ischemia time > 8 hours for first lung and > 8 hours for the second lung

          -  Previously received or is receiving a multi-organ transplant

          -  Pregnant women, nursing mothers or women of child-bearing potential who are unwilling
             to use reliable contraception. Effective contraception must be used BEFORE beginning
             study drug therapy, for the duration of the study and for 6 months following
             completion of the study

          -  Active, extra-pulmonary systemic infection requiring the prolonged or chronic use of
             antimicrobial agents or the presence of a chronic active hepatitis B or C

          -  Active liver disease (liver function tests greater than or equal to 2 times the upper
             limit of normal)

          -  Severe anemia (hemoglobin, < 6 g/dL), leukopenia (WBC < 2500/mm3), thrombocytopenia
             (platelet count < 80,000/mm3), polycythemia (Hct > 54% [male], Hct > 49% [female]) or
             clinically significant coagulopathy

          -  Recipient or donor is seropositive for HIV

          -  Previous exposure or known contraindication to administration of the study drug or to
             rabbit proteins

          -  Current malignancy or a history of malignancy (within the previous 5 years), except
             non-metastatic basal cell or squamous cell carcinoma of the skin or carcinoma in-situ
             of the cervix that has been treated successfully

          -  Unstable cardiovascular disease, or a myocardial infarction within the previous 6
             months

          -  Currently participating in another clinical trial with an investigational agent and/or
             is taking or has been taking an investigational agent in the 30 days prior to
             transplant and/or has not recovered from any reversible side effects of prior
             investigational drug

          -  Unlikely to comply with visits schedule in the protocol

          -  Any current history of substance abuse, psychiatric disorder or a condition that, in
             the opinion of the Investigator, may invalidate communication with the Investigator.