TY - JOUR
T1 - Everolimus with very low-exposure cyclosporine A in de Novo kidney transplantation
T2 - A multicenter, randomized, controlled trial
AU - Salvadori, Maurizio
AU - Scolari, Maria Piera
AU - Bertoni, Elisabetta
AU - Citterio, Franco
AU - Rigotti, Paolo
AU - Cossu, Maria
AU - Dal Canton, Antonio
AU - Tisone, Giuseppe
AU - Albertazzi, Alberto
AU - Pisani, Francesco
AU - Gubbiotti, Giampiero
AU - Piredda, Gianbenedetto
AU - Busnach, Ghil
AU - Sparacino, Vito
AU - Goepel, Volker
AU - Messa, Piergiorgio
AU - Berloco, Pasquale
AU - Montanaro, Domenico
AU - Veroux, Pierfrancesco
AU - Federico, Stefano
AU - Bartezaghi, Marta
AU - Corbetta, Giuseppe
AU - Ponticelli, Claudio
PY - 2009/11
Y1 - 2009/11
N2 - BACKGROUND: In combination with everolimus (EVL), cyclosporine A (CsA) may be used at low exposure, so reducing the risk of renal dysfunction in renal transplant recipients (RTR). We evaluated whether higher exposure of EVL could allow a further reduction of CsA. METHODS: De novo RTR were randomized to standard exposure EVL (C0 3-8 ng/mL) with low-concentration CsA (C2 maintenance levels 350-500 ng/mL, group A) or higher EVL exposure (C0 8-12 ng/mL) with very low-concentration CsA (C2 maintenance levels 150-300 ng/mL, group B). The primary endpoints were 6-month creatinine clearance (CrCl) and biopsy-proven acute rejection (BPAR) rate. After 6 months, patients were followed up (observational extension) to 12 months. RESULTS: Two hundred eighty-five RTR (97% from deceased donors) were enrolled. Two patients per group died (1.4%). The 6-month death-censored graft survival was 90.2% in group A and 97.9% in group B and was unchanged at 12 months (P=0.007). There was no significant difference between groups at 6 months in CrCl (59.9 vs. 57.8 mL/min) and BPAR rates (14.7% vs. 11.9%) and also at 12 months (CrCl 62.5±20.7 vs. 61.3±22.0 mL/min, BPAR 14.7% vs. 14.1%). No significant differences were seen in treated acute rejections, steroid-resistant acute rejections, treatment failures, or delayed graft function, although there was a trend to better results in group B. CONCLUSIONS: EVL given at higher exposure for 6 months plus very low CsA concentration may obtain low acute rejection rate and good graft survival in De novo renal transplantation. However, there was no difference between groups in CrCl.
AB - BACKGROUND: In combination with everolimus (EVL), cyclosporine A (CsA) may be used at low exposure, so reducing the risk of renal dysfunction in renal transplant recipients (RTR). We evaluated whether higher exposure of EVL could allow a further reduction of CsA. METHODS: De novo RTR were randomized to standard exposure EVL (C0 3-8 ng/mL) with low-concentration CsA (C2 maintenance levels 350-500 ng/mL, group A) or higher EVL exposure (C0 8-12 ng/mL) with very low-concentration CsA (C2 maintenance levels 150-300 ng/mL, group B). The primary endpoints were 6-month creatinine clearance (CrCl) and biopsy-proven acute rejection (BPAR) rate. After 6 months, patients were followed up (observational extension) to 12 months. RESULTS: Two hundred eighty-five RTR (97% from deceased donors) were enrolled. Two patients per group died (1.4%). The 6-month death-censored graft survival was 90.2% in group A and 97.9% in group B and was unchanged at 12 months (P=0.007). There was no significant difference between groups at 6 months in CrCl (59.9 vs. 57.8 mL/min) and BPAR rates (14.7% vs. 11.9%) and also at 12 months (CrCl 62.5±20.7 vs. 61.3±22.0 mL/min, BPAR 14.7% vs. 14.1%). No significant differences were seen in treated acute rejections, steroid-resistant acute rejections, treatment failures, or delayed graft function, although there was a trend to better results in group B. CONCLUSIONS: EVL given at higher exposure for 6 months plus very low CsA concentration may obtain low acute rejection rate and good graft survival in De novo renal transplantation. However, there was no difference between groups in CrCl.
KW - Immunosuppression
KW - Kidney transplantation
KW - Randomized clinical trial.
UR - http://www.scopus.com/inward/record.url?scp=73849119625&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=73849119625&partnerID=8YFLogxK
U2 - 10.1097/TP.0b013e3181bb43ec
DO - 10.1097/TP.0b013e3181bb43ec
M3 - Article
C2 - 19935373
AN - SCOPUS:73849119625
VL - 88
SP - 1194
EP - 1202
JO - Transplantation
JF - Transplantation
SN - 0041-1337
IS - 10
ER -