Immunosuppression After Renal Transplantation Clinical Trial
Official title:
Multicenter, Prospective, Randomized Study Investigating the Efficacy and Safety of a Reduced Immunosuppressive Therapy With Tacrolimus Once Daily in Comparison to Standard Triple Immunosuppression in Senior Renal Transplant Recipients
Study purpose To establish efficacy and safety of a reduced immunosuppressive therapy with tacrolimus once daily for senior (>65 years of age) renal transplant recipients
Study outline Stable senior transplant recipients (>65 years of age) participating in the
European SENIOR transplant registry may enter the trial at month 3 post-transplant, if they
fulfil all of the in- and none of the exclusion criteria. At this time patients will be
randomized 1:1 either to continue
Reference therapy:
Tacrolimus once daily (Advagraf®) Mycophenolate (either MMF ≥1g/d or EC-MPS ≥720g/d) Steroids
(≥5mg prednisolone or equivalent) or to Investigational therapy: Tacrolimus once daily
(Advagraf®) Steroid stop at month 3 (tapering within 2 weeks) Mycophenolate stop at month 6
;