Patients with end-stage pulmonary failure, who are receiving a primary single or double pulmonary allograft
Conditions
Interventions
Product Name: Anti-T-lymphocyte Immune Globulin
Product Code: EZ-2053
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: EZ-2053
Other descriptive name: Anti-T-lymphocyt
Sponsors
Fresenius Biotech North America
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - = 18 years of age - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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 - Undergoing second or living donor transplant - Donor lung ischemia time >8 hours - 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 weeks 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 = 2 times upper normal limit) - Severe anemia (hemoglobin, 54% [male], Hct > 49% [female]) or clinically significant coagulopathy - Recipient or donor is seropositive for human immunodeficiency virus (HIV) - Previous exposure or known contraindication to administration of EZ-2053 or rabbit proteins - Current malignancy or a history of malignancy (within the previous 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully - Unstable cardiovascular disease or 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 drug 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 or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator Postoperatively, but prior to randomization, patients with any of the following will be excluded: - Failure to document two measurements of PaO2/FiO2 >200mmHg, separated by 3 hours (+/- 1 hour), with the last measurement within 2 hours of randomization Note: for patients on a nasal cannula, estimate the FiO2 as 4% over 21% for each L/min. For example, 2 L/min = 21 %+ (2 x 4%) = 29%. - Need for extracorporeal membrane oxygenation - Uncontrolled bleeding - Frank evidence of cardiopulmonary instability and/or a patient, who in the estimation of the transplant team, is at high risk for death - Known positive blood culture (any pending microbiology tests should be reviewed prior to randomization)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the efficacy and safety of EZ-2053 9 mg/kg as compared to placebo for prophylaxis of acute pulmonary allograft rejection in adult recipients of a primary pulmonary allograft.;Secondary Objective: .;Primary end point(s): Efficacy failure between placebo and 9 mg/kg EZ-2053 at 12 months post-transplant. Efficacy failure is defined as the first occurrence of death, graft loss, acute rejection (as defined in Section 10.1) and/or loss to follow-up. | — |
Countries
Austria
Outcome results
None listed