title: A prospective randomized trial of steroid-free maintenance regimens in kidney transplant recipients--an interim analysis.
abstract: 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.
authors.affiliation: Department of Surgery, University of Minnesota, Minneapolis, USA. kanda003@umn.edu
authors.forename: Raja
authors.initials: R
authors.lastname: Kandaswamy
authors.forename: J Keith
authors.initials: JK
authors.lastname: Melancon
authors.forename: Ty
authors.initials: T
authors.lastname: Dunn
authors.forename: Miguel
authors.initials: M
authors.lastname: Tan
authors.forename: Vincent
authors.initials: V
authors.lastname: Casingal
authors.forename: Abhinav
authors.initials: A
authors.lastname: Humar
authors.forename: William D
authors.initials: WD
authors.lastname: Payne
authors.forename: Rainer W G
authors.initials: RW
authors.lastname: Gruessner
authors.forename: David L
authors.initials: DL
authors.lastname: Dunn
authors.forename: John S
authors.initials: JS
authors.lastname: Najarian
authors.forename: David E R
authors.initials: DE
authors.lastname: Sutherland
authors.forename: Kristen J
authors.initials: KJ
authors.lastname: Gillingham
authors.forename: Arthur J
authors.initials: AJ
authors.lastname: Matas
mesh_terms: D000961:Antilymphocyte Serum / Q000627:therapeutic use; D016572:Cyclosporine / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D019520:Living Donors; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D016035:Pancreas Transplantation / Q000276:immunology; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use; D016559:Tacrolimus / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus