Science and Research

A randomized trial of everolimus-based quadruple therapy versus standard triple therapy early after lung transplantation

Calcineurin inhibitor (CNI) therapy after lung transplantation increases risk of kidney failure. Early everolimus-based quadruple low CNI immunosuppression may improve renal function without compromising efficacy or safety. A prospective, randomized, open-label, 12-month multicenter trial was conducted at eight German sites. Patients 3-18 months after lung transplantation were randomized (1:1), stratified by baseline estimated glomerular filtration rate (eGFR). In the quadruple low CNI regimen, patients received everolimus (target trough level 3-5 ng/ml) with reduced CNI (tacrolimus 3-5 ng/ml or cyclosporine 25-75 ng/ml) and a cell cycle inhibitor plus prednisone. In the standard triple CNI regimen, patients received tacrolimus (target trough level >5 ng/ml) or cyclosporine (>100 ng/ml) and a cell cycle inhibitor plus prednisone. Of 180 patients screened, 130 were randomized: 67 in the quadruple low CNI group and 63 in the standard triple CNI group. The primary endpoint (eGFR after 12 months) demonstrated superiority of the quadruple low CNI regimen: 64.5 ml/min versus 54.6 ml/min for the standard triple group (least squares mean, ANCOVA; p<0.001). Key efficacy parameters (biopsy-proven acute rejection, chronic lung allograft dysfunction, death) and safety endpoints were similar between both groups. Quadruple low CNI immunosuppression early after lung transplantation was demonstrated to be efficacious and safe. This article is protected by copyright. All rights reserved.
  • Gottlieb, J.
  • Neurohr, C.
  • Muller-Quernheim, J.
  • Wirtz, H.
  • Sill, B.
  • Wilkens, H.
  • Bessa, V.
  • Knosalla, C.
  • Porstner, M.
  • Capusan, C.
  • Struber, M.
Publication details
DOI: 10.1111/ajt.15251
Journal: American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
Work Type: Original
Location: BREATH
Disease Area: ROR
Partner / Member: MHH
Access-Number: 30615259

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