Study design and preliminary results of the italian everolimus registry CERTIC in Kidney Transplant Patients

Everolimus is licensed for the prevention of acute rejection in heart or kidney transplant recipients. In comparison with standard immunosuppression, everolimus may display some important benefits, such as lower incidence of malignancies, lower incidence of CMV infections, and better preservation of renal function. To gain information on the safety and efficacy of long-term use of everolimus in de novo and maintenance patients in the clinical practice, we designed the CERTIC observational study. Between 2008 and 2010, 783 kidney and heart transplant recipients who were on therapy with everolimus since at least 6 months were enrolled into a 5-year follow-up registry. Death, graft loss, major cardiovascular events (MACE), malignancies, acute rejections, glomerular filtration rate, and main clinical and biological parameters were recorded.
Herein we present the main follow-up data of the kidney transplant (KT) recipients cohort (385 patients, 1% pediatrics) after one year. Enrolled patients were under everolimus-based regimen since a mean of 2 yrs before entering the registry. Of 383 KT recipients, 336 (88%) patients received everolimus within three months from transplant (de novo group), and only 47 (12%) started everolimus 1.6 1.6 y post-KT (maintenance group). In de novo group, (age 50 12 yrs, 69% males) the 1-yr survival rate was 98% and six patients (1.8%) developed a neoplasm. In maintenance group (age 45 17 yrs, 75% males), survival rate was 91% and two patients (4.2%) developed malignancies. Estimated glomerular filtration rate (eGFR), calculated with the MDRD formula, remained stable during everolimus treatment in both de novo group (from 54.1 22.8 to 52.9 23.4 ml/min/1.73 m2) and maintenance patients (from 56.8 39.2 to 57.0 32.3 ml/min/1.73 m2). This large prospective registry will provide the longest-term available data on safety and efficacy of everolimus therapy in KT recipients. This initial report shows high survival rates, low incidences of malignancies and a stable renal function in patients receiving everolimus, supporting the promising concept of a long-term benefit of this drug both in de novo and maintenance KT patients.