title: A Prospective Randomised Paired Trial of Sirolimus versus Tacrolimus as Primary Immunosuppression following Non-Heart Beating Donor Kidney Transplantation.
abstract: BACKGROUND
  With calcineurin inhibitors potentiating damage from ischaemia-reperfusion injury in kidneys from donors after cardiac death we wanted to investigate the role of substituting sirolimus for tacrolimus in the delayed introduction of calcineurin inhibitor regime used in our centre.
  
  
  METHODS
  A prospective randomised paired open-label study was performed taking pairs of kidneys from each donor and randomising one to a tacrolimus-based regime and the other to a similar regime based on sirolimus. Graft function at one year was the primary endpoint.
  
  
  RESULTS
  Total 31 pairs of kidneys were randomised to each group, with 19 pairs of recipients available for analysis after post-randomisation study exclusions. Despite a higher incidence of biopsy proven acute rejection in the sirolimus group, renal allograft function was similar in both groups at three-monthly intervals up to one year post-transplant. All episodes of acute rejection in the sirolimus group occurred in the first three months. Graft and patient survival at one year was 100% in the tacrolimus group, with one death with functioning graft in the sirolimus group (95% survival). Unfortunately, 10 of the 19 patients in the sirolimus arm required switch of medication to tacrolimus due to acute rejection or intolerable drug side effects.
  
  
  CONCLUSIONS
  Graft survival and function were very similar in the two groups despite the higher rate of acute rejection in the sirolimus arm, raising the possibility that the damage done by acute rejection was adequately offset by the nephron-sparing effect of sirolimus compared to tacrolimus. Sirolimus may have a role as a longer-term maintenance immunosuppressant after initial treatment with a different agent such as tacrolimus or belatacept.
authors.affiliation: Renal Transplant Unit, Western Infirmary, Glasgow.
authors.forename: John
authors.initials: J
authors.lastname: Asher
authors.affiliation: Department of Hepatobiliary and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Nikhil
authors.initials: N
authors.lastname: Vasdev
authors.affiliation: Department of Hepatobiliary and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Hugh
authors.initials: H
authors.lastname: Wyrley-Birch
authors.affiliation: Department of Hepatobiliary and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Wilson
authors.affiliation: Department of Hepatobiliary and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Naeem
authors.initials: N
authors.lastname: Soomro
authors.affiliation: Department of Hepatobiliary and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: David
authors.initials: D
authors.lastname: Rix
authors.affiliation: Department of Hepatobiliary and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Bryon
authors.initials: B
authors.lastname: Jaques
authors.affiliation: Department of Hepatobiliary and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Derek
authors.initials: D
authors.lastname: Manas
authors.affiliation: Department of Hepatobiliary and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Torpey
authors.affiliation: Department of Hepatobiliary and Transplant Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: David
authors.initials: D
authors.lastname: Talbot
keywords: Transplantation