ELITE-Symphony

Efficacy Limiting Toxicity Elimination — Symphony Study

Patient / Population Intervention / Exposure Comparison Outcome

In 1,645 kidney-transplant recipients, low-dose tacrolimus with mycophenolate and steroids gave better graft function than the other immunosuppressive regimens.

1,645

Design

Open-label RCT, four arms

Endpoint

eGFR at 12 months

Relevance

ResultLow-dose tacrolimus 65.4 mL/min (superior; p<0.001); biopsy-proven rejection 12.3% and graft survival 94.2%.

Ekberg H, et al. N Engl J Med. 2007;357(25):2562-2575. 10.1056/NEJMoa067411

Discussion & critique

Established low-dose tacrolimus plus mycophenolate and steroids as the de-novo standard.