Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Azathioprine; Calcineurin Inhibitors; Everolimus; Immunosuppressive Agents; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

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.