TRANSFORM Study 2013.

Trial name or title	Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus‐based regiMen (TRANSFORM)
Methods	Multicentre, open‐label RCT
Participants	Recipient of a primary (or secondary, if 1st graft is not lost due to immunological reasons) kidney transplant from a deceased heart beating, living‐unrelated, living‐related non‐HLA identical or an expanded criteria donor. Randomised within 24 h of completion of transplant surgery
Interventions	Treatment group EVL trough level: 3 to 8 ng/mL Reduced exposure to CNI (CsA or TAC) Control group MPS or MMF Standard exposure to CNI (CsA or TAC)
Outcomes	Incidence of failure on the composite of treated BPAR or eGFR < 50 mL/min/1.73 m2 Incidence of failure on the composite of BPAR, graft loss or death Kidney function: eGFR CMV BK virus NODAT CKD with associated proteinuria CNI‐associated adverse events
Starting date	December 2013
Contact information	Novartis Pharmaceuticals
Notes

AR ‐ acute rejection; ATG ‐ antithymocyte globulin; BPAR ‐ biopsy‐proven acute rejection; CKD ‐ chronic kidney disease; CMV ‐ cytomegalovirus; CNI ‐ calcineurin inhibitor; CsA ‐ cyclosporin A; DM ‐ diabetes mellitus; EVL ‐ everolimus; (e)GFR ‐ (estimated) glomerular filtration rate; MMF ‐ mycophenolate mofetil; MPS ‐ mycophenolate sodium; NODAT ‐ new onset diabetes after transplantation; PRED ‐ prednisone/prednisolone; RCT ‐ randomised controlled trial; TAC ‐ tacrolimus