title: Inferior results with basis immunosuppression with sirolimus in kidney transplantation.
abstract: BACKGROUND
  The introduction of sirolimus has provided the opportunity to develop an immunosuppressive regimen without the nephrotoxic calcineurin inhibitors.
  
  
  METHODS
  We conducted a first trial in 30 renal allograft recipients. Ten patients were followed prospectively and received sirolimus, to achieve a target blood level of 10 to 15 ng/ml, induction therapy with one dose of daclizumab, low-dose steroids and mycophenolate mofetil. We compared this group with a historical control group of 20 patients who received our standard treatment consisting of tacrolimus, low-dose steroids, and mycophenolate mofetil.
  
  
  RESULTS
  After a mean follow-up of 15 weeks, seven patients developed an acute rejection in the sirolimus group (70%) compared with three patients in the tacrolimus group (15%) (p.<0.01). Because of this unacceptable high rate of acute rejections we conducted a second prospective pilot study in nine patients. These patients received sirolimus in combination with two doses of daclizumab, high-dose steroids and mycophenolate mofetil. No rejections occurred under this immunosuppressive regimen; however, many immunosuppression-related adverse events were seen.
  
  
  CONCLUSIONS
  The present study demonstrates an unacceptably high rate of acute rejections (70%) in patients treated with sirolimus, daclizumab, mycophenolate mofetil and low-dose prednisolone. No rejections but many adverse events were seen when sirolimus was given in combination with high-dose steroids.
authors.affiliation: Department of Internal Medicine, Division of Nephrology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
authors.forename: J M
authors.initials: JM
authors.lastname: van den Akker
authors.forename: R J
authors.initials: RJ
authors.lastname: Hené
authors.forename: A J
authors.initials: AJ
authors.lastname: Hoitsma
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000077561:Daclizumab; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011239:Prednisolone / Q000627:therapeutic use; D020123:Sirolimus / Q000009:adverse effects / Q000627:therapeutic use*; D016559:Tacrolimus / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D011239:Prednisolone; D000077561:Daclizumab; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus