Design of a trial comparing sirolimus plus mycophenolate mofetil versus sirolimus plus cyclosporine.
We present the study design of a prospective, multicenter, randomized trial aimed at comparing the effects of two different combinations of sirolimus. Renal transplant recipients will be allocated to receive either sirolimus and mycophenolate mofetil (group A) or sirolimus and cyclosporine (group B). The primary endpoint will be the graft function at 3, 6, 12, 24, 36, 48, and 60 months. A number of secondary endpoints will also be considered. To obtain a significant difference in the primary endpoint 180 patients will be enrolled.
Ponticelli
C
C
Renal unit Ospedale Maggiore, Milano, Italy. ponticelli@policlinico.mi.it
Tarantino
A
A
Aroldi
A
A
Sparacino
V
V
Stefoni
S
S
Citterio
F
F
Duca
L
L
Scolari
M P
MP
Calabrese
S
S
Altieri
P
P
Civati
G
G
Cesana
B
B
D000328:Adult; D000368:Aged; D016572:Cyclosporine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006085:Graft Survival / Q000187:drug effects / Q000276:immunology*; D006650:Histocompatibility Testing; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D020123:Sirolimus / Q000627:therapeutic use*
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid; D020123:Sirolimus