Randomized trial of Alemtuzumab for prevention of graft rejection and preservation of renal function after kidney transplantation

• Published in: Transplantation Vol. 80; no. 6; p. 765
• Main Authors: Vathsala, Anantharaman, Ona, Enrique T, Tan, Si-Yen, Suresh, Shirley, Lou, Huei-Xin, Casasola, Concesa B Cabanayan, Wong, Hung-Chew, Machin, David, Chiang, Gilbert S C, Danguilan, Romina A, Calne, Roy
• Format: Journal Article
• Language: English
• Published: United States 27.09.2005
• Subjects: Adolescent; Adult; Aged; Alemtuzumab; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - pharmacology; Antibodies, Monoclonal, Humanized; Antibodies, Neoplasm - administration & dosage; Antibodies, Neoplasm - pharmacology; Cyclosporine - pharmacokinetics; Female; Graft Rejection - immunology; Graft Rejection - prevention & control; Humans; Immunotherapy; Kidney - drug effects; Kidney - immunology; Kidney - physiology; Kidney Function Tests; Kidney Transplantation; Male; Middle Aged; Time Factors
• ISSN: 0041-1337
• DOI: 10.1097/01.tp.0000166921.14670.33

A randomized, multicenter, controlled trial was undertaken to evaluate the safety and efficacy of Alemtuzumab, a powerful lytic agent for both T and B lymphocytes, in the prophylaxis of rejection in renal transplantation (RTx). Thirty patients were randomized to receive Alemtuzumab together with low-dose cyclosporine (CsA) monotherapy (CAMPATH, n = 20) or to full doses of CsA with azathioprine and corticosteroids (Standard, n = 10). CsA was administered at doses to achieve whole-blood trough CsA levels of 90 to 110 ng/mL and 180 to 225 ng/mL in CAMPATH and Standard groups, respectively. Per protocol, CsA trough levels were lower in patients assigned to CAMPATH post-RTx (median trough level of 119 vs. 166 ng/mL at 6 months, CAMPATH vs. Standard; 95% confidence interval, -92 to -34). At 6 months post-RTx, serum creatinine, graft and patient survivals, incidence of biopsy proven acute rejection (25% vs. 20%, CAMPATH vs. Standard), overall treatment failure, and severe and moderate infections were comparable. Whereas all patients receiving Standard therapy required maintenance corticosteroids at 6 months, of the 17 of 20 patients with functioning grafts in CAMPATH, 15 (88%, 95% confidence interval, 53%-97%) were steroid free. These results suggest that Alemtuzumab is an effective induction agent that permits low-dose steroid-free immunosuppression in RTx.