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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
Statement of
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
Rights: © 2012 The Authors
DOI: 10.1111/nep.12004
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