Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation

Launched by NOVARTIS PHARMACEUTICALS · Sep 15, 2006

Keywords

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Gender

ALL

Eligibility criteria

• 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.