TRANSFORM
Transplant Efficacy and Safety Outcomes with an Everolimus-based Regimen
Doente / População Intervenção / Exposição Comparação Desfecho
In 2,037 de-novo kidney-transplant recipients, everolimus with reduced calcineurin inhibitor was non-inferior for rejection, graft loss or death compared with mycophenolate with standard calcineurin inhibitor.
N
2037
Desenho
Open-label RCT
Desfecho
Treated biopsy-proven acute rejection or eGFR <50 ml/min/1.73m² at 12 months (non-inferiority, 10% margin)
Relevância
3
Resultado48.2% vs 45.1% (difference 3.2%, 95% CI −1.3 to 7.6); non-inferior. Discontinuation for AEs 23.0% vs 11.9%.
Pascual J, et al. J Am Soc Nephrol. 2018;29(7):1979-1991. 10.1681/ASN.2018010009
Discussão e crítica
The largest de-novo mTOR-inhibitor trial; tolerability limits uptake.