title: Long-term graft outcomes after steroid withdrawal in African American kidney transplant recipients receiving sirolimus and tacrolimus.
abstract: BACKGROUND
  We previously reported excellent short-term outcomes in African American kidney transplant patients receiving tacrolimus/sirolimus and withdrawn from corticosteroid therapy three months after transplantation. We now report the long-term outcomes of patients subjected to this protocol.
  
  
  METHODS
  In all, 47 African American kidney transplant recipients were enrolled in an uncontrolled trial in which they were initially treated with sirolimus, tacrolimus, and corticosteroids, without antibody induction therapy. Eligible patients were withdrawn from prednisone between three and five months posttransplant, and followed for acute rejection and changes in renal function. Outcomes (group 1, n=32) were compared to those of patients deemed not to be candidates for steroid withdrawal (group 2, n=15).
  
  
  RESULTS
  After a mean follow-up of 48.5 months, 13 of 32 patients (41%) in group 1 developed acute rejection; only 13 patients (41%) remain steroid-free. Nine of 13 rejection episodes were associated with noncompliance. Graft loss occurred in 8 of 32 patients (25%) in group 1 and in 5 of 15 patients (33%) in group 2 (P=NS). Serum creatinine rose from 1.4+/-0.41 to 2.45+/-1.7 mg/dL in group 1 (P=0.004) and from 2.1+/-0.45 to 2.62+/-1.2 mg/dL (P=NS) in group 2. Among 13 patients in group 1 who remain steroid-free, creatinine concentration has risen from 1.28+/-.0.37 prior to steroid withdrawal to 1.64+0.54 at last follow-up (P=0.027).
  
  
  CONCLUSIONS
  Late noncompliance and/or rejection in African Americans withdrawn from steroids have a negative impact on long-term graft function and survival. Steroid withdrawal may be associated with long-term deterioration of renal function, even in the absence of overt acute rejection.
authors.affiliation: Department of Medicine, Case Western Reserve University, Cleveland, OH, USA. deh5@po.cwru.edu
authors.forename: Donald E
authors.initials: DE
authors.lastname: Hricik
authors.forename: Joshua J
authors.initials: JJ
authors.lastname: Augustine
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Knauss
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Bodziak
authors.forename: Mark
authors.initials: M
authors.lastname: Aeder
authors.forename: Christopher
authors.initials: C
authors.lastname: Siegel
authors.forename: James A
authors.initials: JA
authors.lastname: Schulak
mesh_terms: D000328:Adult; D001741:Black or African American; D003404:Creatinine / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000627:therapeutic use*; D013256:Steroids / Q000627:therapeutic use; D016559:Tacrolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D013256:Steroids; D003404:Creatinine; D020123:Sirolimus; D016559:Tacrolimus