Advantage of Rapamycin Over Mycophenolate Mofetil When Used with Tacrolimus for Simultaneous Pancreas Kidney Transplants: Randomized, Single-Center Trial at 10 Years.
Ciancio G, Sageshima J, et al.American Journal of Transplantation [record in progress]
Aims
To establish the long-term efficacy of mycophenolate mofetil (MMF) versus sirolimus in simultaneous kidney-pancreas transplantation.
Interventions
Sirolimus (4 mg/day, target levels of 5–7 ng/mL) versus MMF (1 g, twice a day) started postoperatively on day 1. All patients received dual induction therapy with thymoglobulin and daclizumab, and low-dose maintenance tacrolimus and corticosteroids.
Participants
170 patients with type 1 diabetes and end-stage renal disease
Outcomes
The primary endpoints were kidney- and pancreas-specific biopsy-proven acute rejection rates during the first 12 months posttransplant. Secondary endpoints included biopsy-proven or clinically treated acute rejection throughout the follow-up period, allograft loss (kidney and pancreas specific, both death-censored and uncensored), infection, other adverse events and death.
Follow-up
10 years
CET Conclusions
This paper reports the 10 year follow up of recipients of simultaneous kidney-pancreas transplants randomized to receive either MMF or Rapamycin in addition to Tacrolimus and steroid immune-suppression. Biopsy-proven acute rejection rates were improved for both pancreases and kidneys in the Rapamycin group at 10 years. When clinically suspected (but not biopsied) episodes of rejection were included as well, there was still a benefit for pancreases but not kidneys at 10 years. There were no differences between the groups in death-censored or uncensored kidney or pancreas survival. There was a high rate (52%) of patients who discontinued or withheld immune-suppression in the MMF group during the first year which may account for the difference in acute rejection rates.
Data analysis
Strict intention-to-treat analysis
Trial registration
Clinical Trials.gov - NCT00533442