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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tre…
What they're measuring
1
Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12