CLINICAL RESEARCHMycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus NephritisAppel, Gerald B.; Contreras, Gabriel; Dooley, Mary Anne; Ginzler, Ellen M.; Isenberg, David; Jayne, David; Li, Lei-Shi; Mysler, Eduardo; Sa[Combining Acute Accent]nchez-Guerrero, Jorge; Solomons, Neil; Wofsy, David the Aspreva Lupus Management Study Group Author Information *Department of Nephrology, Columbia University, New York, New York; †University of Miami, Miller School of Medicine, Miami, Florida; ‡Department of Medicine, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina; §Department of Medicine, SUNY-Downstate Medical Center, New York, New York; ‖Centre for Rheumatology, Department of Medicine, University College London, London, United Kingdom; ¶Renal Unit, Addenbrooke's Hospital, Cambridge, United Kingdom; **Research Institute of Nephrology, Nanjing, China; ††Organizacio[Combining Acute Accent]n Me[Combining Acute Accent]dica de Investigacio[Combining Acute Accent]n, Buenos Aires, Argentina; ‡‡Instituto Nacional de Ciencias Me[Combining Acute Accent]dicas y Nutricio[Combining Acute Accent]n, Salvador Zubira[Combining Acute Accent]n, Me[Combining Acute Accent]xico; §Aspreva Pharmaceuticals Corporation, Victoria, British Columbia, Canada; and ‖Department of Medicine, University of California, San Francisco, California Correspondence: Dr. Neil Solomons, Aspreva Pharmaceuticals Corporation, #1203, 4464 Markham Street, Victoria, BC V8Z7X8, Canada. Phone: 250-708-4287; Fax: 254-744-2498; E-mail: [email protected] Accepted December 5, 2008 Received October 1, 2008 Journal of the American Society of Nephrology 20(5):p 1103-1112, May 2009. | DOI: 10.1681/ASN.2008101028 Buy Metrics Abstract Recent studies have suggested that mycophenolate mofetil (MMF) may offer advantages over intravenous cyclophosphamide (IVC) for the treatment of lupus nephritis, but these therapies have not been compared in an international randomized, controlled trial. Here, we report the comparison of MMF and IVC as induction treatment for active lupus nephritis in a multinational, two-phase (induction and maintenance) study. We randomly assigned 370 patients with classes III through V lupus nephritis to open-label MMF (target dosage 3 g/d) or IVC (0.5 to 1.0 g/m2 in monthly pulses) in a 24-wk induction study. Both groups received prednisone, tapered from a maximum starting dosage of 60 mg/d. The primary end point was a prespecified decrease in urine protein/creatinine ratio and stabilization or improvement in serum creatinine. Secondary end points included complete renal remission, systemic disease activity and damage, and safety. Overall, we did not detect a significantly different response rate between the two groups: 104 (56.2%) of 185 patients responded to MMF compared with 98 (53.0%) of 185 to IVC. Secondary end points were also similar between treatment groups. There were nine deaths in the MMF group and five in the IVC group. We did not detect significant differences between the MMF and IVC groups with regard to rates of adverse events, serious adverse events, or infections. Although most patients in both treatment groups experienced clinical improvement, the study did not meet its primary objective of showing that MMF was superior to IVC as induction treatment for lupus nephritis. Copyright © 2009 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.