Abstract | BACKGROUND: 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:
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Authors | C Ponticelli, A Yussim, V Cambi, C Legendre, G Rizzo, M Salvadori, D Kahn, H Kashi, K Salmela, L Fricke, U Heemann, J Garcia-Martinez, R Lechler, H Prestele, D Girault, Simulect Phase IV Study Group |
Journal | Transplantation
(Transplantation)
Vol. 72
Issue 7
Pg. 1261-7
(Oct 15 2001)
ISSN: 0041-1337 [Print] United States |
PMID | 11602853
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Immunosuppressive Agents
- Recombinant Fusion Proteins
- Steroids
- Cyclosporine
- Basiliximab
- Azathioprine
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Topics |
- Adult
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Azathioprine
(therapeutic use)
- Basiliximab
- Cyclosporine
(therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Graft Rejection
(epidemiology, prevention & control)
- Graft Survival
- Humans
- Immunosuppressive Agents
(adverse effects, therapeutic use)
- Incidence
- Kidney Transplantation
- Male
- Middle Aged
- Preventive Medicine
(methods)
- Recombinant Fusion Proteins
- Safety
- Steroids
(therapeutic use)
- Survival Analysis
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