Enteric-coated mycophenolate sodium in combination with full dose or reduced dose cyclosporine, basiliximab and corticosteroids in Australian de novo kidney transplant patients.

Cyclosporine (CsA), dosed to achieve C2 targets, has been shown to provide safe and efficacious immunosuppression when used with a mycophenolate and steroids for de novo kidney transplant recipients. This study examined whether use of enteric-coated mycophenolate sodium (EC-MPS) together with basiliximab and steroids would enable use of CsA dosed to reduced C2 targets in order to achieve improved graft function. Twelve-month, prospective, randomized, open-label trial in de novo kidney transplant recipients in Australia. Seventy-five patients were randomized to receive either usual exposure (n = 33) or reduced exposure (n = 42) CsA, EC-MPS 720 mg twice daily, basiliximab and corticosteroids. There was no significant difference in mean Cockcroft-Gault CrCl (creatinine clearance) (60.2 ± 17.6 mL/min per 1.73 m(2) vs 63.2 ± 24.3, P = 0.64 for usual versus reduced exposure respectively) at 6 months. There was no significant difference between treatment groups in the incidence of treatment failure defined as biopsy proven acute rejection, graft loss or death (secondary endpoint: 30.3% full exposure vs 35.7% reduced exposure). At 12 months the incidence of overall adverse events was the same in both groups. This exploratory study suggests de novo renal transplant patients can safely receive a treatment regimen of either full or reduced exposure CsA in combination with EC-MPS, corticosteroids and basiliximab, with no apparent difference in efficacy or graft function during the first year after transplant.

Chadban S ，Eris J ，Russ G ，Campbell S ，Chapman J ，Pussell B ，Trevillian P ，Ierino F ，Thomson N ，Hutchison B ，Irish A ，Woodcock C ，Kurstjens N ，Walker R ，MyProms AU01 Study Group ... -  《-》

Reduced-exposure cyclosporine is safe and efficacious in de novo renal transplant recipients treated with enteric-coated mycophenolic acid and basiliximab.

Budde K ，Bosmans JL ，Sennesael J ，Zeier M ，Pisarski P ，Schütz M ，Fischer W ，Neumayer HH ，Glander P ... -  《CLINICAL NEPHROLOGY》

Renal function with cyclosporine C2 monitoring, enteric-coated mycophenolate sodium and basiliximab: a 12-month randomized trial in renal transplant recipients.

Cibrik D ，Meier-Kriesche HU ，Bresnahan B ，Wu YM ，Klintmalm G ，Kew CE ，Kuo PC ，Whelchel J ，Cohen D ，Baliga P ，Akalin E ，Benedetti E ，Wright F ，Lieberman B ，Ulbricht B ，Jensik S ，Myfortic-US01 Renal Transplant Study Group ... -  《CLINICAL TRANSPLANTATION》

A single-centre, open-label, prospective study of an initially short-term intensified dosing regimen of enteric-coated mycophenolate sodium with reduced cyclosporine A exposure in Chinese live-donor kidney transplant recipients.

The nephrotoxicity of cyclosporine A (CsA) accounts for dysfunction of kidney allografts in the clinic. Short-term intensified dosing using enteric-coated mycophenolate sodium (EC-MPS) may facilitate CsA sparing after kidney transplantation without compromising safety. In a 12-month, single-centre open-label prospective trial, 180 de novo live-donor kidney transplant recipients at low-immunological risk were randomised to a low-dose cyclosporine group which received a low dose of cyclosporine, short-term intensified EC-MPS dosing (2160 mg/day to week 6, 1440 mg/day thereafter) and corticosteroids or a standard-dose cyclosporine group which received a standard dose of cyclosporine, standard EC-MPS dosing (1440 mg/day) and corticosteroids. The primary end-point [treatment failure including biopsy-proven acute rejection (BPAR), graft loss, death], secondary end-point and adverse events were monitored. The primary end-point (treatment failure) occurred in 13.3% (12/90) of the low-dose cyclosporine group and 16.7% (15/90) of the standard-dose cyclosporine group (p = 0.53) (difference -3.4%, 95% confidence interval -11.7% to 7.5%, based on a noninferiority margin of 20%). BPAR occurred in 11.1% and 13.3% of patients in the low-dose cyclosporine group and standard-dose cyclosporine group, respectively (p = 0.65). The estimated glomerular filtration rate, as calculated by the Cockcroft-Gault formula, was similar at 12 months after transplantation (low-dose cyclosporine group 63 ± 19 ml/min/1.73 m(2) and standard-dose cyclosporine group 59 ± 15 ml/min/1.73 m(2) ; p = 0.43). The levels of serum creatinine and occurrence of adverse events between the two groups were not statistically different. A regimen of early intensified EC-MPS dosing permits low-dose cyclosporine in live-donor kidney transplant patients at low-immunological risk without compromising efficacy at 12 months' follow-up.

Cai L ，Zeng F ，Liu B ，Wei L ，Chen Z ，Jiang J ... -  《-》

Safety and efficacy of the early introduction of everolimus with reduced-exposure cyclosporine a in de novo kidney recipients.

Oh CK ，Huh KH ，Ha J ，Kim YH ，Kim YL ，Kim YS ... -  《-》