Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/83323
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Type: Journal article
Title: Enteric-coated mycophenolate sodium in combination with full dose or reduced dose cyclosporine, basiliximab and corticosteroids in Australian de novo kidney transplant patient
Author: 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.
Citation: Nephrology, 2013; 18(1):63-70
Publisher: Blackwell Publishing Asia
Issue Date: 2013
ISSN: 1320-5358
1440-1797
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Responsibility: 
Steve Chadban, Josette Eris, Graeme Russ, Scott Campbell, Jeremy Chapman, Bruce Pussell, Paul Trevillian, Francesco Ierino, Napier Thomson, Brian Hutchison, Ashley Irish, Chad Woodcock, Nicol Kurstjens and Rowan Walker: The Myproms Au Study Group
Abstract: AIM 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. METHODS 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. RESULTS 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. CONCLUSION 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.
Keywords: calcineurin inhibitor
cyclosporine
transplantation
Rights: © 2012 The Authors
DOI: 10.1111/nep.12004
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