title: Enteric-coated mycophenolate sodium in combination with full dose or reduced dose cyclosporine, basiliximab and corticosteroids in Australian de novo kidney transplant patients.
abstract: OBJECTIVE
  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 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Transplantation, Royal Prince Alfred Hospital, Sydney, Australia. steve.chadban@sswahs.nsw.gov.au
authors.forename: Steve
authors.initials: S
authors.lastname: Chadban
authors.forename: Josette
authors.initials: J
authors.lastname: Eris
authors.forename: Graeme
authors.initials: G
authors.lastname: Russ
authors.forename: Scott
authors.initials: S
authors.lastname: Campbell
authors.forename: Jeremy
authors.initials: J
authors.lastname: Chapman
authors.forename: Bruce
authors.initials: B
authors.lastname: Pussell
authors.forename: Paul
authors.initials: P
authors.lastname: Trevillian
authors.forename: Francesco
authors.initials: F
authors.lastname: Ierino
authors.forename: Napier
authors.initials: N
authors.lastname: Thomson
authors.forename: Brian
authors.initials: B
authors.lastname: Hutchison
authors.forename: Ashley
authors.initials: A
authors.lastname: Irish
authors.forename: Chad
authors.initials: C
authors.lastname: Woodcock
authors.forename: Nicol
authors.initials: N
authors.lastname: Kurstjens
authors.forename: Rowan
authors.initials: R
authors.lastname: Walker
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D001315:Australia; D000077552:Basiliximab; D016572:Cyclosporine / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D013608:Tablets, Enteric-Coated; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D013608:Tablets, Enteric-Coated; D016572:Cyclosporine; D000077552:Basiliximab; D009173:Mycophenolic Acid