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.
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.
Mourad
Georges
G
Department of Nephrology-Transplantation, Hôpital Lapeyronie, Montpellier, France. g-mourad@chu-montpellier.fr
Karras
Alexandre
A
Kamar
Nassim
N
Garrigue
Valérie
V
Legendre
Christophe
C
Lefrançois
Nicole
N
Charpentier
Bernard
B
Bourbigot
Bernard
B
Pouteil-Noble
Claire
C
Bayle
François
F
Lebranchu
Yvon
Y
Mariat
Christophe
C
Le Meur
Yann
Y
Kessler
Michèle
M
Moulin
Bruno
B
Ducloux
Didier
D
Delahousse
Michel
M
Lang
Philippe
P
Merville
Pierre
P
Chaouche-Teyara
Kamel
K
Rostaing
Lionel
L
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
D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D016572:Cyclosporine; D003404:Creatinine