Reference : 5-Year outcomes of the prospective and randomized cistcert study comparing steroid wi...
Scientific journals : Article
Human health sciences : Urology & nephrology
5-Year outcomes of the prospective and randomized cistcert study comparing steroid withdrawal to replacement of cyclosporine with everolimus in de novo kidney transplant patients.
Pipeleers, Lissa [> >]
Abramowicz, Daniel [> >]
Broeders, Nilufer [> >]
Lemoine, Alain [> >]
Peeters, Patrick [> >]
Van Laecke, Steven [> >]
WEEKERS, Laurent mailto [Centre Hospitalier Universitaire de Liège - CHU > Département de médecine interne > Service de néphrologie >]
Sennesael, Jacques [> >]
Wissing, Karl M. [> >]
Geers, Caroline [> >]
Bosmans, Jean-Louis [> >]
Transplant international : official journal of the European Society for Organ Transplantation
Yes (verified by ORBi)
[en] CNI ; Cyclosporine ; Everolimus ; Immunosuppression ; Kidney transplantation ; mTORi
[en] BACKGROUND: Withdrawal of either steroids or calcineurin inhibitors are two strategies to reduce treatment-related side effects and improve long-term outcomes of kidney transplantation. The Cistcert study compared the efficacy and safety of these two strategies. METHODS: In this multi-center, randomized controlled trial, 151 incident kidney transplant recipients received cyclosporine (CsA), mycophenolic acid (MPA) and steroids during three months, followed by either steroid withdrawal (CsA/MPA) or replacement of cyclosporine with everolimus (EVL) (EVL/MPA/steroids). RESULTS: Five-year patient (89% vs 86%; p=NS) and death-censored graft survival (95% vs 96%; p=NS) were comparable in the CsA/MPA and EVL/MPA/steroids arm respectively. (51) CrEDTA clearance was comparable in the intention-to-treat analysis, but in the on-treatment population, the EVL/MPA/steroids arm exhibited a superior (51) CrEDTA clearance at 1 and 5 years after transplantation (61.6 vs 52.4, p=0.05 and 59.1 vs 46.2mL/min/1.73 m(2) , p=0.042). Numerically more and more severe rejections were observed in the EVL/MPA/steroids arm, which also experienced a higher incidence of post-transplant diabetes (26% versus 6%, p=0.0016) and infections. No significant differences were observed in cardiovascular outcomes and malignancy. CONCLUSIONS: Both regimens provide an excellent long-term patient and graft survival. Regarding graft function, EVL/MPA/steroids is an attractive strategy for patients with good tolerability who remain free of rejection.
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