A randomized trial of everolimus‐based quadruple therapy vs standard triple therapy early after lung transplantation
Abstract: 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 8 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 the 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 vs 54.6 mL/min for the standard triple group (least squares mean, analysis of covariance; P < .001). Key efficacy parameters (biopsy‐proven acute rejection, chronic lung allograft dysfunction, and death) and safety endpoints were similar between both groups. Quadruple low CNI immunosuppression early after lung transplantation was demonstrated to be efficacious and safe
- Location
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Deutsche Nationalbibliothek Frankfurt am Main
- Extent
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Online-Ressource
- Language
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Englisch
- Notes
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issn: 1600-6143
- Keyword
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Klinisches Experiment
Ciclosporin
Everolimus
Lungentransplantation
Transplantatabstoßung
Tacrolimus
- Event
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Veröffentlichung
- (where)
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Freiburg
- (who)
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Universität
- (when)
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2019
- Creator
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Gottlieb, Jens Tobias
Neurohr, Claus
Müller-Quernheim, Joachim
Wirtz, Hubert
Sill, Björn
Wilkens, Heinrike
Bessa, Vasiliki
Knosalla, Christoph
Porstner, Martina
Capusan, Carmen
Strüber, Martin
- DOI
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10.1111/ajt.15251
- URN
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urn:nbn:de:bsz:25-freidok-1499943
- Rights
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Der Zugriff auf das Objekt ist unbeschränkt möglich.
- Last update
- 15.08.2025, 7:33 AM CEST
Data provider
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Associated
- Gottlieb, Jens Tobias
- Neurohr, Claus
- Müller-Quernheim, Joachim
- Wirtz, Hubert
- Sill, Björn
- Wilkens, Heinrike
- Bessa, Vasiliki
- Knosalla, Christoph
- Porstner, Martina
- Capusan, Carmen
- Strüber, Martin
- Universität
Time of origin
- 2019
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