Improved pulse wave velocity and renal function in individualized calcineurin inhibitor treatment by immunomonitoring: the randomized controlled calcineurin inhibitor-sparing trial
BACKGROUND: A new immune monitoring tool which assesses the expression of nuclear factor of activated T cells (NFAT)-regulated genes measures the functional effects of cyclosporine A. This is the first prospective randomized controlled study to compare standard pharmacokinetic monitoring by cyclospo...
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| Main Authors: | , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
March 2018
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| In: |
Transplantation
Year: 2018, Volume: 102, Issue: 3, Pages: 510-520 |
| ISSN: | 1534-6080 |
| DOI: | 10.1097/TP.0000000000001973 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1097/TP.0000000000001973
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| Author Notes: | Claudia Sommerer, Janina Brocke, Thomas Bruckner, Matthias Schaier, Christian Morath, Stefan Meuer, Martin Zeier, Thomas Giese |
| Summary: | BACKGROUND: A new immune monitoring tool which assesses the expression of nuclear factor of activated T cells (NFAT)-regulated genes measures the functional effects of cyclosporine A. This is the first prospective randomized controlled study to compare standard pharmacokinetic monitoring by cyclosporine trough levels to NFAT-regulated gene expression (NFAT-RE). - METHODS: Expression of the NFAT-regulated genes was determined by qRT-PCR at cyclosporine trough and peak level. Cardiovascular risk was assessed by change of pulse wave velocity from baseline to month 6. Clinical follow-up was 12 months. - RESULTS: In total, 55 stable kidney allograft recipients were enrolled. Mean baseline residual NFAT-RE was 13.1 ± 9.1%. Patients in the NFAT-RE group showed a significant decline in pulse wave velocity from baseline to month 6 versus the standard group (-1.7 ± 2.0 m/s vs 0.4 ± 1.4 m/s, P < 0.001). Infections occurred more often in the standard group compared with the immune monitoring group. No opportunistic infections occurred with NFAT-RE monitoring. At 12 months of follow-up, renal function was significantly better with NFAT-RE versus standard monitoring (Nankivell glomerular filtration rate: 68.5 ± 17.4 mL/min vs 57.2 ± 19.0 mL/min; P = 0.009). - CONCLUSIONS: NFAT-RE as translational immune monitoring tool proved efficacious and safe in individualizing cyclosporine therapy, with the opportunity to reduce the cardiovascular risk and improve long-term renal allograft function. |
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| Item Description: | Gesehen am 27.03.2020 |
| Physical Description: | Online Resource |
| ISSN: | 1534-6080 |
| DOI: | 10.1097/TP.0000000000001973 |