The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial
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). Th...
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| Language: | English |
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Wiley
2017-01-01
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| Series: | Journal of Transplantation |
| Online Access: | http://dx.doi.org/10.1155/2017/6347138 |
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| author | Jan Van Keer David Derthoo Olivier Van Caenegem Michel De Pauw Eric Nellessen Nathalie Duerinckx Walter Droogne Gábor Vörös Bart Meyns Ann Belmans Stefan Janssens Johan Van Cleemput Johan Vanhaecke |
| author_facet | Jan Van Keer David Derthoo Olivier Van Caenegem Michel De Pauw Eric Nellessen Nathalie Duerinckx Walter Droogne Gábor Vörös Bart Meyns Ann Belmans Stefan Janssens Johan Van Cleemput Johan Vanhaecke |
| author_sort | Jan Van Keer |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e72bfb6a0bf14aae862ccfb3449e4fd1 |
| institution | Kabale University |
| issn | 2090-0007 2090-0015 |
| language | English |
| publishDate | 2017-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Transplantation |
| spelling | doaj-art-e72bfb6a0bf14aae862ccfb3449e4fd12025-08-20T03:26:11ZengWileyJournal of Transplantation2090-00072090-00152017-01-01201710.1155/2017/63471386347138The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized TrialJan Van Keer0David Derthoo1Olivier Van Caenegem2Michel De Pauw3Eric Nellessen4Nathalie Duerinckx5Walter Droogne6Gábor Vörös7Bart Meyns8Ann Belmans9Stefan Janssens10Johan Van Cleemput11Johan Vanhaecke12Department of Cardiology, University Hospitals Leuven, 3000 Leuven, BelgiumDepartment of Cardiology, University Hospitals Leuven, 3000 Leuven, BelgiumDepartment of Cardiology, Cliniques Universitaires Saint-Luc, 1200 Bruxelles, BelgiumDepartment of Cardiology, University Hospitals Ghent, 9000 Ghent, BelgiumDepartment of Cardiology, Centre Hospitalier Universitaire de Liège-Sart Tilman, 4000 Liège, BelgiumDepartment of Cardiology, University Hospitals Leuven, 3000 Leuven, BelgiumDepartment of Cardiology, University Hospitals Leuven, 3000 Leuven, BelgiumDepartment of Cardiology, University Hospitals Leuven, 3000 Leuven, BelgiumDepartment of Cardiac Surgery, University Hospitals Leuven, 3000 Leuven, BelgiumInteruniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University & Catholic University of Leuven, 3000 Leuven, BelgiumDepartment of Cardiology, University Hospitals Leuven, 3000 Leuven, BelgiumDepartment of Cardiology, University Hospitals Leuven, 3000 Leuven, BelgiumDepartment of Cardiology, University Hospitals Leuven, 3000 Leuven, BelgiumIn 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.http://dx.doi.org/10.1155/2017/6347138 |
| spellingShingle | Jan Van Keer David Derthoo Olivier Van Caenegem Michel De Pauw Eric Nellessen Nathalie Duerinckx Walter Droogne Gábor Vörös Bart Meyns Ann Belmans Stefan Janssens Johan Van Cleemput Johan Vanhaecke 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 |
| title | The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial |
| title_full | The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial |
| title_fullStr | The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial |
| title_full_unstemmed | The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial |
| title_short | The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial |
| title_sort | cecari study everolimus certican r initiation and calcineurin inhibitor withdrawal in maintenance heart transplant recipients with renal insufficiency a multicenter randomized trial |
| url | http://dx.doi.org/10.1155/2017/6347138 |
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