title: Prospective randomized trial of maintenance immunosuppression with rapid discontinuation of prednisone in adult kidney transplantation.
abstract: Rapid discontinuation of prednisone (RDP) has minimized steroid-related complications following kidney transplant (KT). This trial compares long-term (10-year) outcomes with three different maintenance immunosuppressive protocols following RDP in adult KT. Recipients (n=440; 73% living donor) from March 2001 to April 2006 were randomized into one of three arms: cyclosporine (CSA) and mycophenolate mofetil (MMF) (CSA/MMF, n=151); high-level tacrolimus (TAC, 8-12 μg/L) and low-level sirolimus (SIR, 3-7 μg/L) (TACH/SIRL, n=149) or low-level TAC (3-7 μg/L) and high-level SIR (8-12 μg/L) (TACL/SIR(H) , n=140). Median follow-up was ∼7 years. There were no differences between arms in 10-year actuarial patient, graft and death-censored graft survival or in allograft function. There were no differences in the 10-year actuarial rates of biopsy-proven acute rejection (30%, 26% and 20% in CSA/MMF, TACH/SIRL and TACL/SIRH) and chronic rejection (38%, 35% and 31% in CSA/MMF, TACH/SIRL and TACL/SIRH). Rates of new-onset diabetes mellitus were higher with TACH/SIRL (p=0.04), and rates of anemia were higher with TACH/SIRL and TACL/SIRH (p=0.04). No differences were found in the overall rates of 16 other post-KT complications. These data indicate that RDP-based protocol yield acceptable 10-year outcomes, but side effects differ based on the maintenance regimen used and should be considered when optimizing immunosuppression following RDP.
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: T M
authors: TM
authors: Suszynski
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: K J
authors: KJ
authors: Gillingham
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: M D
authors: MD
authors: Rizzari
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: T B
authors: TB
authors: Dunn
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: W D
authors: WD
authors: Payne
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: S
authors: S
authors: Chinnakotla
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: E B
authors: EB
authors: Finger
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: D E R
authors: DER
authors: Sutherland
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: J S
authors: JS
authors: Najarian
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: T L
authors: TL
authors: Pruett
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: A J
authors: AJ
authors: Matas
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: R
authors: R
authors: Kandaswamy
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000627:therapeutic use; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis; D005260:Female; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000379:methods*; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011183:Postoperative Complications; D011241:Prednisone / Q000627:therapeutic use*; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use; D013256:Steroids / Q000627:therapeutic use; D016559:Tacrolimus / Q000627:therapeutic use; D013997:Time Factors; D014184:Transplantation, Homologous; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D013256:Steroids; D016572:Cyclosporine; D009173:Mycophenolic Acid; D011241:Prednisone; D020123:Sirolimus; D016559:Tacrolimus