Alemtuzumab (Campath‐1H) and Tacrolimus Monotherapy After Renal Transplantation: Results of a Prospective Randomized Trial

• Published in: American journal of transplantation Vol. 8; no. 7; pp. 1480 - 1485
• Main Authors: Margreiter, R., Klempnauer, J., Neuhaus, P., Muehlbacher, F., Boesmueller, C., Calne, R. Y.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.07.2008; Blackwell
• Subjects: Adolescent; Adult; Aged; Alemtuzumab; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Humanized; Antibodies, Neoplasm - therapeutic use; Biological and medical sciences; Cytomegalovirus; Drug Therapy, Combination; Female; Graft Rejection - drug therapy; Graft Rejection - prevention & control; Graft Survival - drug effects; Humans; Immunosuppressive Agents - therapeutic use; Kidney Transplantation; Male; Medical sciences; Middle Aged; Mycophenolic Acid - analogs & derivatives; Mycophenolic Acid - therapeutic use; Pharmacology. Drug treatments; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the urinary system; Tacrolimus - therapeutic use; tacrolimus monotherapy; Treatment Outcome; Antineoplastic agent; Calcineurin inhibitor; Campath-1H; Monoclonal antibody; Homotransplantation; Kidney; Result; Prospective; Randomization; Surgery; Immunotherapy; Graft; Clinical trial; Protein synthesis inhibitor; Lactone; Alemtuzumab; tacrolimus monotherapy; Macrolide; Immunomodulator; Treatment; Urinary system; Tacrolimus; Immunosuppressive agent; Antibacterial agent; Monotherapy; Kidney transplantation
• ISSN: 1600-6135; 1600-6143
• DOI: 10.1111/j.1600-6143.2008.02273.x

The lymphocyte‐depleting antibody alemtuzumab was evaluated in a prospective randomized multicenter trial in deceased donor kidney transplantation. The 65 patients in the study group received induction with alemtuzumab followed by delayed tacrolimus monotherapy, while the 66 patients in the control group were started on tacrolimus in combination with mycophenolate mofetil and steroids. Tacrolimus levels of 8–12 ng/mL for the first 6 months and 5–8 ng/mL thereafter were aimed for in both groups. At 12 months the biopsy‐proven rejection rate was 20% in the study group and 32% in the control group (p = 0.09). Patient survival at 1 year was 98% for both groups. Graft survival was 96% for the study group versus 90% for the control group (p = 0.18). Graft function was identical in both groups. Adverse events were similar in both groups apart for more CMV infections in the study group. At the end of the first year 82% of the patients in the study group were steroid‐free and 71% continued on tacrolimus monotherapy. These results suggest that alemtuzumab induction together with tacrolimus monotherapy is at least as efficient in renal transplantation as is a tacrolimus‐based triple‐drug regimen with a similar safety profile but more CMV infections. Alemtuzumab preconditioning followed by tacrolimus monotherapy in renal transplant recipients is safe and at least as efficient as a tacrolimus based triple‐drug regimen.