title: Renal function with delayed or immediate cyclosporine microemulsion in combination with enteric-coated mycophenolate sodium and steroids: results of follow up to 30 months post-transplant.
abstract: BACKGROUND
  In the multicenter, open-label Myriade study, renal transplant patients were randomized to early cyclosporine microemulsion (CsA-ME, day 0) or delayed CsA-ME (day 6) with enteric-coated mycophenolate sodium (EC-MPS), steroids and interleukin-2 receptor induction. One-yr results have been published previously. We now report the results of an extension study in which patients were followed up for a period of three yr post-transplant.
  
  
  METHODS
  All patients completing the one-yr core study on-treatment were eligible to enter the extension study.
  
  
  RESULTS
  Of the 203 patients, 153 completed the core trial on-treatment; 144 (94%) entered the extension study with a minimum follow-up of one yr (73 early CsA-ME, 71 delayed CsA-ME). In 75% of patients receiving EC-MPS during the extension, the recommended dose was administered (1440 mg/d). Median creatinine clearance remained constant (57 mL/min) at 12, 24 and 30 months post-transplant and was similar in the early and delayed CsA-ME groups as well as in subpopulations with or without delayed graft function. One patient in the early CsA-ME group died. No grafts were lost. The incidence of BPAR from time of transplant to the end of the extension study was 17% (24/139). Seven patients (5%) discontinued the extension study prematurely because of adverse events.
  
  
  CONCLUSIONS
  These results suggest that a regimen of CsA-ME, EC-MPS and steroids results in excellent survival rates with stable renal function over a mean follow-up of 30 months. Immediate introduction of CsA-ME has no deleterious effect on long-term renal function, even among patients with delayed graft function.
authors.affiliation: Department of Nephrology-Transplantation, Hôpital Lapeyronie, Montpellier, France. g-mourad@chu-montpellier.fr
authors.forename: Georges
authors.initials: G
authors.lastname: Mourad
authors.forename: Alexandre
authors.initials: A
authors.lastname: Karras
authors.forename: Nassim
authors.initials: N
authors.lastname: Kamar
authors.forename: Valérie
authors.initials: V
authors.lastname: Garrigue
authors.forename: Christophe
authors.initials: C
authors.lastname: Legendre
authors.forename: Nicole
authors.initials: N
authors.lastname: Lefrançois
authors.forename: Bernard
authors.initials: B
authors.lastname: Charpentier
authors.forename: Bernard
authors.initials: B
authors.lastname: Bourbigot
authors.forename: Claire
authors.initials: C
authors.lastname: Pouteil-Noble
authors.forename: François
authors.initials: F
authors.lastname: Bayle
authors.forename: Yvon
authors.initials: Y
authors.lastname: Lebranchu
authors.forename: Christophe
authors.initials: C
authors.lastname: Mariat
authors.forename: Yann
authors.initials: Y
authors.lastname: Le Meur
authors.forename: Michèle
authors.initials: M
authors.lastname: Kessler
authors.forename: Bruno
authors.initials: B
authors.lastname: Moulin
authors.forename: Didier
authors.initials: D
authors.lastname: Ducloux
authors.forename: Michel
authors.initials: M
authors.lastname: Delahousse
authors.forename: Philippe
authors.initials: P
authors.lastname: Lang
authors.forename: Pierre
authors.initials: P
authors.lastname: Merville
authors.forename: Kamel
authors.initials: K
authors.lastname: Chaouche-Teyara
authors.forename: Lionel
authors.initials: L
authors.lastname: Rostaing
mesh_terms: D003404:Creatinine / Q000097:blood; D016572:Cyclosporine / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007668:Kidney / Q000503:physiopathology; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000276:immunology; D008297:Male; D008875:Middle Aged; D013608:Tablets, Enteric-Coated; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D016572:Cyclosporine; D003404:Creatinine