Minimizing Immunosuppression in Old for Old Kidney Transplantation
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the
decreased injury threshold of older grafts may limit the benefits of transplantation in these
patients. To compare favourable effects between low dose tacrolimus (LD-Tac) and
mycophenolate-mofetil (MMF) in this patient population the investigators conducted a one year
prospective multicenter randomized controlled trial. 90 kidney transplant recipients > 65
years with cadaveric grafts (> 65 years) from 5 centers were enrolled and received baseline
immunosuppression with daclizumab induction (1 mg/kg) at day one and day 14, LD-Tac (trough
level 5-8 µg/ml), MMF (1-2 g/d) and steroids. After three months, patients were centrally
randomized either to MMF (1-2 g/d) and steroids (23 patients) or to LD-Tac and steroids.
Follow-up visits were performed every 4 weeks up to one year. Protocol biopsies were
performed after one year. The investigators' primary hypothesis is that the biopsy proven
rejection rate in the MMF group is not significantly different compared to the LD-Tac group
after one year. The investigators' secondary hypothesis is that graft function in the MMF
group (reflected by the glomerular filtration rate and protocol biopsy result) is superior to
the graft function in the LD-Tac group.