Enteric-coated mycophenolate sodium in combination with full dose or reduced dose cyclosporine, basiliximab and corticosteroids in Australian de novo kidney transplant patients
Version of Record online: 17 DEC 2012
© 2012 The Authors. Nephrology © 2012 Asian Pacific Society of Nephrology
Volume 18, Issue 1, pages 63–70, January 2013
How to Cite
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. and the MyProms AU01 Study Group (2013), Enteric-coated mycophenolate sodium in combination with full dose or reduced dose cyclosporine, basiliximab and corticosteroids in Australian de novo kidney transplant patients. Nephrology, 18: 63–70. doi: 10.1111/nep.12004
- Issue online: 17 DEC 2012
- Version of Record online: 17 DEC 2012
- Accepted manuscript online: 30 OCT 2012 03:34AM EST
- Manuscript Accepted: 18 OCT 2012
- Novartis Pharmaceuticals Australia
- calcineurin inhibitor;
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 m2 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.