A randomized, double-blind trial of basiliximab immunoprophylaxis plus triple therapy in kidney transplant recipients.
BACKGROUND
A double-blind, placebo-controlled, randomized study was performed to assess whether immunoprophylaxis with basiliximab (Simulect) could reduce the incidence of acute rejection in kidney transplant recipients treated with cyclosporine (Neoral), steroids, and azathioprine.


METHODS
Three hundred forty patients received either placebo or basiliximab at a dose of 20 mg, given intravenously on days 0 and 4. All patients received cyclosporine, steroids, and azathioprine. The primary endpoint was the incidence of acute rejection at 6 months. Secondary endpoints included the safety and tolerability of basiliximab and placebo, 1-year patient and graft survival, and significant medical events up to 12 months.


RESULTS
During the first 6 months posttransplantation, acute rejection occurred in 20.8% of patients given basiliximab versus 34.9% of patients administered placebo (P=0.005). Similarly, there was a reduction in biopsy-proven acute rejection at 6 months in the patients receiving basiliximab (P=0.023). One-year patient survival was 97.6% with basiliximab and 97.1% with placebo, graft survival was 91.5% versus 88.4%, respectively (NS). The adverse-events profile of patients treated with basiliximab was indistinguishable from that of patients treated with placebo. The number of patients with infections was similar (65.5% for basiliximab vs. 65.7% for placebo), including cytomegalovirus infections (17.3% vs. 14.5%, P=0.245). Nine neoplasms (three in the basiliximab group, six in the placebo arm) were recorded up to 1 year from transplantation.


CONCLUSIONS
Basiliximab in combination with cyclosporine, steroids, and azathioprine triple therapy was highly effective in reducing the incidence of acute renal allograft rejection without increasing the incidence of infections and other side effects.
Ponticelli
C
C
Divisione Nefrologia e Dialisi, IRCCS Ospedale Maggiore Policlinico, Via Commenda 15, 20122, Milano, Italy.
Yussim
A
A
Cambi
V
V
Legendre
C
C
Rizzo
G
G
Salvadori
M
M
Kahn
D
D
Kashi
H
H
Salmela
K
K
Fricke
L
L
Heemann
U
U
Garcia-Martinez
J
J
Lechler
R
R
Prestele
H
H
Girault
D
D
D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use; D000077552:Basiliximab; D016572:Cyclosporine / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011315:Preventive Medicine / Q000379:methods*; D011993:Recombinant Fusion Proteins; D012449:Safety; D013256:Steroids / Q000627:therapeutic use; D016019:Survival Analysis
D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D013256:Steroids; D016572:Cyclosporine; D000077552:Basiliximab; D001379:Azathioprine