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Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation.
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2018 (English)In: Journal of the American Society of Nephrology, ISSN 1046-6673, E-ISSN 1533-3450, Vol. 29, no 7, p. 1979-1991Article in journal (Refereed) Published
Abstract [en]

Background Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation.Methods In a multicenter noninferiority trial, we randomized 2037 de novo kidney transplant recipients to receive, in combination with induction therapy and corticosteroids, everolimus with reduced-exposure CNI (everolimus arm) or mycophenolic acid (MPA) with standard-exposure CNI (MPA arm). The primary end point was treated biopsy-proven acute rejection or eGFR<50 ml/min per 1.73 m2 at post-transplant month 12 using a 10% noninferiority margin.Results In the intent-to-treat population (everolimus n=1022, MPA n=1015), the primary end point incidence was 48.2% (493) with everolimus and 45.1% (457) with MPA (difference 3.2%; 95% confidence interval, -1.3% to 7.6%). Similar between-treatment differences in incidence were observed in the subgroups of patients who received tacrolimus or cyclosporine. Treated biopsy-proven acute rejection, graft loss, or death at post-transplant month 12 occurred in 14.9% and 12.5% of patients treated with everolimus and MPA, respectively (difference 2.3%; 95% confidence interval, -1.7% to 6.4%). De novo donor-specific antibody incidence at 12 months and antibody-mediated rejection rate did not differ between arms. Cytomegalovirus (3.6% versus 13.3%) and BK virus infections (4.3% versus 8.0%) were less frequent in the everolimus arm than in the MPA arm. Overall, 23.0% and 11.9% of patients treated with everolimus and MPA, respectively, discontinued the study drug because of adverse events.Conclusions In kidney transplant recipients at mild-to-moderate immunologic risk, everolimus was noninferior to MPA for a binary composite end point assessing immunosuppressive efficacy and preservation of graft function.

Place, publisher, year, edition, pages
2018. Vol. 29, no 7, p. 1979-1991
Keywords [en]
calcineurin inhibitor, efficacy graft, everolimus, function, kidney transplantation, randomized
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-397512DOI: 10.1681/ASN.2018010009PubMedID: 29752413OAI: oai:DiVA.org:uu-397512DiVA, id: diva2:1371959
Note

Bengt von Zur-Mühlen är forskare i gruppen TRANSFORM investigators, han tillhör Uppsala universitet, institutionen för kirurgiska vetenskaper, taransplatationskirurgi. 

Available from: 2019-11-21 Created: 2019-11-21 Last updated: 2019-11-21

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