Prospective comparison of the use of sirolimus and cyclosporine in recipients of a kidney from an expanded criteria donor.
A 6-month, open-label, multicenter prospective pilot study was conducted to evaluate the effects of sirolimus (SRL) versus cyclosporine (CsA) in recipients of kidneys from expanded criteria donors. All patients also received antithymocyte globulins induction, mycophenolate mofetil, and steroids. Sixty-nine patients (33 SRL, 36 CsA) were randomized. More patient were withdrawn in the SRL group (16 vs. 6, P<0.01), because of delayed graft function and surgical complications. Delayed graft function tended to be more frequent with SRL than with CsA (45.4% vs. 30.6%, P=0.22). Graft survival was numerically lower in the SRL group (87.5% vs. 97%, P=0.19). At 6 months, there were no significant differences in biopsy-proven acute rejection or calculated creatinine clearance (SRL 12.1% vs. CsA 8.3%; P=0.7 and 44.7+/-16.6 vs. 41.9+/-15.2 mL/min; P=0.54 respectively). These results do not support the use of SRL immediately after transplantation in expanded criteria donor recipients.
Durrbach
Antoine
A
Department of Nephrology and Transplantation, Hôpital du Kremlin-Bicêtre, Le Kremlin-Bicêtre, Paris, France.
Rostaing
Lionel
L
Tricot
Leila
L
Ouali
Nacera
N
Wolf
Philippe
P
Pouteil-Noble
Claire
C
Kessler
Michele
M
Viron
Beatrice
B
Thervet
Eric
E
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D016572:Cyclosporine / Q000009:adverse effects / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D006084:Graft Rejection; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D007668:Kidney / Q000503:physiopathology; D016030:Kidney Transplantation; D008875:Middle Aged; D010865:Pilot Projects; D020123:Sirolimus / Q000009:adverse effects / Q000494:pharmacology*; D014019:Tissue Donors
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D020123:Sirolimus