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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
Author(s) -
Mourad Georges,
Karras Alexandre,
Kamar Nassim,
Garrigue Valérie,
Legendre Christophe,
Lefrançois Nicole,
Charpentier Bernard,
Bourbigot Bernard,
PouteilNoble Claire,
Bayle François,
Lebranchu Yvon,
Mariat Christophe,
Meur Yann Le,
Kessler Michèle,
Moulin Bruno,
Ducloux Didier,
Delahousse Michel,
Lang Philippe,
Merville Pierre,
ChaoucheTeyara Kamel,
Rostaing Lionel
Publication year - 2007
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/j.1399-0012.2007.00660.x
Subject(s) - medicine , enteric coated , renal transplant , mycophenolate , renal function , urology , sodium , transplantation , kidney transplantation , surgery , gastroenterology , chemistry , organic chemistry
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. Conclusion: 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.