title: A multicenter pilot study of early (4-day) steroid cessation in renal transplant recipients under simulect, tacrolimus and sirolimus.
abstract: This study presents the first prospective multicenter study assessing sirolimus-based immunosuppression with early (4-day) corticosteroid withdrawal (CSWD) in renal transplantation. Immunosuppression included: anti-IL-2 receptor antibody and tacrolimus/sirolimus. Inclusion criteria included adult primary recipients. Exclusion criteria included: (i) African Americans, (ii) current PRA >50%, (iii) multiple organ transplants, (iv) WBC < 3000 cells/microL and (v) fasting hypercholesterolemia/hypertriglyceridemia. The primary endpoints were acute rejection and the proportion of patients off corticosteroids. Seventy-seven patients were enrolled: mean age of 49.7 +/- 12 years. Transplants included: cadaveric (26%) and living donor (74%). Patient and graft survival were 100%. Biopsy proven acute rejection occurred in 13%; presumptive rejection in 10.5%. Banff grades included: IA (seven patients), IB (one patient), IIA (one patient) and IIB (one patient). Renal function at 1 year: serum creatinine (1.18 +/- 0.06 mg/dL). Mean weight gain was minimal at 1 year: 3 +/- 2 kg/patient. Mild increases in total, LDL and HDL cholesterol were observed and new antilipid agent use occurred in 26 patients. In conclusion, early CSWD under tacrolimus/sirolimus-based immunosuppression in selected, low-risk renal transplant recipients provides: (i) excellent patient and graft survival, (ii) good renal function, (iii) reduced hyperlipidemia and antilipid agent use and (iv) low acute rejection rates.
authors.affiliation: Division of Transplantation, Department of Surgery, University of Cincinnati, School of Medicine, Cincinnati, OH, USA. woodlees@uc.edu
authors.forename: E Steve
authors.initials: ES
authors.lastname: Woodle
authors.forename: Flavio
authors.initials: F
authors.lastname: Vincenti
authors.forename: Marc I
authors.initials: MI
authors.lastname: Lorber
authors.forename: H Albin
authors.initials: HA
authors.lastname: Gritsch
authors.forename: Donald
authors.initials: D
authors.lastname: Hricik
authors.forename: Kenneth
authors.initials: K
authors.lastname: Washburn
authors.forename: Arthur J
authors.initials: AJ
authors.lastname: Matas
authors.forename: Michael
authors.initials: M
authors.lastname: Gallichio
authors.forename: John
authors.initials: J
authors.lastname: Neylan
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000077552:Basiliximab; D001706:Biopsy; D001794:Blood Pressure; D001835:Body Weight; D002102:Cadaver; D002319:Cardiovascular System; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003404:Creatinine / Q000097:blood; D005260:Female; D006084:Graft Rejection; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007239:Infections / Q000209:etiology; D016030:Kidney Transplantation / Q000379:methods*; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D012307:Risk Factors; D020123:Sirolimus / Q000627:therapeutic use*; D013256:Steroids / Q000627:therapeutic use*; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D013256:Steroids; D000077552:Basiliximab; D003404:Creatinine; D020123:Sirolimus; D016559:Tacrolimus