Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation

Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation: Results at 24 Months

This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.

Inclusion criteria:

• Patients who have undergone a heart or lung transplantation more than 12 months ago.
• Patients receiving Neoral® or Prograf®.
• Patients with a measured or calculated glomerular filtration rate (GFR) > 20 and < 70 mL/min/1.73m^2. For patients with a GFR > 60 and < 70 mL/min/1.73m^2, a deteriorated renal function since the time of transplantation must be documented by at least one post-transplant GFR level that is > 10% above the GFR level at the time of inclusion.
• Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months.
• Females of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.

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.