A Prospective Randomized Trial of Steroid‐Free Maintenance Regimens in Kidney Transplant Recipients—An Interim Analysis

• Published in: American journal of transplantation Vol. 5; no. 6; pp. 1529 - 1536
• Main Authors: Kandaswamy, Raja, Melancon, J. Keith, Dunn, Ty, Tan, Miguel, Casingal, Vincent, Humar, Abhinav, Payne, William D., Gruessner, Rainer W. G., Dunn, David L., Najarian, John S., Sutherland, David E. R., Gillingham, Kristen J., Matas, Arthur J.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Munksgaard International Publishers 01-06-2005; Blackwell
• Subjects: Antilymphocyte Serum - therapeutic use; Biological and medical sciences; Cyclosporine - therapeutic use; Drug Therapy, Combination; Graft Rejection - prevention & control; Graft Survival; Humans; Immunosuppression; Immunosuppressive Agents - therapeutic use; kidney transplant; Kidney Transplantation; Living Donors; Medical sciences; Middle Aged; Mycophenolic Acid - analogs & derivatives; Mycophenolic Acid - therapeutic use; Pancreas Transplantation - immunology; prospective; Prospective Studies; Sirolimus - therapeutic use; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Tacrolimus - therapeutic use; Treatment Outcome; śteroid‐free; Steroid; Corticosteroid; kidney transplant; Transplantation; Homotransplantation; Kidney; Prospective; Immunosuppression; Treatment; Urinary system; Surgery; Graft; Clinical trial; Immunosuppressive agent; steroid-free
• ISSN: 1600-6135; 1600-6143
• DOI: 10.1111/j.1600-6143.2005.00885.x

We compared three maintenance immunosuppressive regimens in a rapid discontinuation of prednisone protocol. From March 1, 2001, through December 31, 2003, 239 first and second kidney transplant recipients (166 LD; 73 DD) were randomized. All recipients were treated with Thymoglobulin; all received steroids intraoperatively and for 5 days postoperatively. Randomization was to cyclosporine–mycophenolate mofetil (n = 85); high‐level tacrolimus (TAC) (8–12 ng/mL)–low‐level sirolimus (SRL) (3–7 ng/mL) (n = 72); or low‐level TAC (3–7 ng/mL)–high‐level SRL (8–12 ng/mL) (n = 82). We found no difference at 24 months between groups in patient, graft, death‐censored graft, or acute rejection‐free graft survival, or in kidney function.
Wound complications were more common in SRL‐treated recipients (p = 0.02); we found no other differences between groups in complication rates. Our data suggest that excellent patient and graft survival and low rejection rates can be obtained using a variety of maintenance protocols without prednisone.