Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation

Exclusion Criteria

• •Patients who are recipients of multiple organ transplants.
• •Patients with measured GFR \< 20 mL/min/1.73m\^2 or \> 70 mL/min/1.73m\^2.
• •Patients with a treated acute rejection episode within the last 3 months.
• •Patients with a platelet count of \< 50,000/mm\^3 or with a white blood cell count of ≤ 2,500/mm\^3 or with a hemoglobin value \< 8 g/dL.
• •Presence of severe hypercholesterolemia (≥ 8.0 mmol/L) or hypertriglyceridemia (≥ 6.0 mmol/L) despite conventional lipid lowering treatment.
• •Patients currently treated or who have been treated with a mammalian target of rapamycin (mTOR) inhibitor.
• •Patients who have received an investigational drug within 4 weeks.
• •Patients who are human immunodeficiency virus positive or who have a current severe systemic infection requiring continued therapy according to investigator judgment.
• •Present use of any immunosuppressive drugs other than Neoral®/Prograf®, mycophenolic acid/azathioprine (MPA/AZA), and/or steroids.
• •Patients with a known hypersensitivity to drugs similar to everolimus.
• •Symptoms of significant mental illness which, in the opinion of the investigator, may interfere with the patient's ability to comply with the protocol. History of drug or alcohol abuse within 1 year of baseline.
• •Inability to cooperate or communicate with the investigator.
• •Patients with any past (within the last 5 years) or present malignancy other than excised squamous or basal cell carcinoma.
• •Females of childbearing potential that are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use effective means of contraception.
• •Patients with a planned coronary revascularization or patients who have experienced a major adverse cardiovascular event (MACE) within the last 3 months.