The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial
Joint Authors
Van Keer, Jan
De Pauw, Michel
Derthoo, David
Van Caenegem, Olivier
Nellessen, Eric
Duerinckx, Nathalie
Droogne, Walter
Vörös, Gábor
Belmans, Ann
Janssens, Stefan
Van Cleemput, Johan
Vanhaecke, Johan
Meyns, B.
Source
Issue
Vol. 2017, Issue 2017 (31 Dec. 2017), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2017-02-20
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
In this 3-year, open-label, multicenter study, 57 maintenance heart transplant recipients (>1 year after transplant) with renal insufficiency (eGFR 30–60 mL/min/1.73 m2) were randomized to start everolimus with CNI withdrawal (N=29) or continue their current CNI-based immunosuppression (N=28).
The primary endpoint, change in measured glomerular filtration rate (mGFR) from baseline to year 3, did not differ significantly between both groups (+7.0 mL/min in the everolimus group versus +1.9 mL/min in the CNI group, p=0.18).
In the on-treatment analysis, the difference did reach statistical significance (+9.4 mL/min in the everolimus group versus +1.9 mL/min in the CNI group, p=0.047).
The composite safety endpoint of all-cause mortality, major adverse cardiovascular events, or treated acute rejection was not different between groups.
Nonfatal adverse events occurred in 96.6% of patients in the everolimus group and 57.1% in the CNI group (p<0.001).
Ten patients (34.5%) in the everolimus group discontinued the study drug during follow-up due to adverse events.
The poor adherence to the everolimus therapy might have masked a potential benefit of CNI withdrawal on renal function.
American Psychological Association (APA)
Van Keer, Jan& Derthoo, David& Van Caenegem, Olivier& De Pauw, Michel& Nellessen, Eric& Duerinckx, Nathalie…[et al.]. 2017. The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial. Journal of Transplantation،Vol. 2017, no. 2017, pp.1-8.
https://search.emarefa.net/detail/BIM-1187990
Modern Language Association (MLA)
Van Keer, Jan…[et al.]. The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial. Journal of Transplantation No. 2017 (2017), pp.1-8.
https://search.emarefa.net/detail/BIM-1187990
American Medical Association (AMA)
Van Keer, Jan& Derthoo, David& Van Caenegem, Olivier& De Pauw, Michel& Nellessen, Eric& Duerinckx, Nathalie…[et al.]. The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial. Journal of Transplantation. 2017. Vol. 2017, no. 2017, pp.1-8.
https://search.emarefa.net/detail/BIM-1187990
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1187990