title: Favorable results of concomitant tacrolimus and sirolimus therapy in Taiwanese renal transplant recipients at 12 months.
abstract: OBJECTIVE
  Combined therapy of sirolimus and cyclosporine has been found to exacerbate cyclosporine-related nephrotoxicity and to imperil graft renal function. We hypothesized that tacrolimus could bring about better renal function than cyclosporine when used in combination with sirolimus and corticosteroids for de novo renal transplantation.
  
  
  METHODS
  A two-arm randomized study was conducted to test the hypothesis. Patients who gave written informed consent and received renal transplantation were randomized to take sirolimus in combination with either tacrolimus or cyclosporine. The primary endpoint of this study was renal function, and the secondary endpoints were acute rejection, graft and patient survival, metabolic side effects and infectious complications.
  
  
  RESULTS
  A total of 41 Taiwanese renal transplant patients were randomized to receive cyclosporine (CsA group, n = 20) or tacrolimus (TAC group, n = 21) in combination with sirolimus and corticosteroids. The average estimated glomerular filtration rate (eGFR) was 52.77 +/- 3.86 mL per minute for the TAC group at 6 months, and 46.42 +/- 3.95 mL per minute for the CsA group (p > 0.05). At 12 months, the average eGFR was 52.04 +/- 4.38 mL per minute for the TAC group, and 46.79 +/- 4.38 mL per minute for the CsA group (p > 0.05). The biopsy-proven acute rejection rate of the TAC group was 4.76% (1/21), and that of the CsA group was 5.00% (1/20) at 12 months. The 12-month graft survival rates for the TAC and CsA groups were 100% and 90% (p = 0.142), respectively.
  
  
  CONCLUSIONS
  Our study demonstrated that concomitant tacrolimus and sirolimus therapy resulted in a favorable outcome in Taiwanese renal transplant patients at 12 months. Large-scale clinical trials will be needed to further address the issue of which calcineurin inhibitor, cyclosporine or tacrolimus, provides better renal function and graft survival for renal transplant patients.
authors.affiliation: Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Kuo-Hsin
authors.initials: KH
authors.lastname: Chen
authors.forename: Meng-Kun
authors.initials: MK
authors.lastname: Tsai
authors.forename: I-Rue
authors.initials: IR
authors.lastname: Lai
authors.forename: Fe-Lin
authors.initials: FL
authors.lastname: Lin Wu
authors.forename: Rey-Heng
authors.initials: RH
authors.lastname: Hu
authors.forename: Po-Huang
authors.initials: PH
authors.lastname: Lee
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage; D005260:Female; D005919:Glomerular Filtration Rate; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation; D008297:Male; D020123:Sirolimus / Q000008:administration & dosage*; D016559:Tacrolimus / Q000008:administration & dosage*
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D020123:Sirolimus; D016559:Tacrolimus