A randomized trial of intensified vs. standard dosing for enteric-coated mycophenolate sodium in de novo kidney transplant recipients: results at 1 year
In a 6-month prospective, openlabel, multicenter study, 128 de novo kidney transplant patients receiving cyclosporine (CsA) and steroids were randomized to an intensified regimen of enteric-coated mycophenolate sodium (EC-MPS) or to a standard EC-MPS regimen to Week 6 posttransplant, after which the...
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| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2013
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| In: |
Clinical nephrology
Year: 2013, Volume: 79, Issue: 6, Pages: 421-431 |
| DOI: | 10.5414/CN107908 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.5414/CN107908
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| Author Notes: | Wolfgang Arns, Claudia Sommerer, Petra Glander, Toofan Ariatabar, Martina Porstner, Christoph May, Eva-Maria Paulus, Maria Shipkova, Wolfgang Fischer, Lutz Liefeldt, Ruth Hackenberg, Peter Schemmer, Sophie Domhan, Martin Zeier, Klemens Budde |
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| 520 | |a In a 6-month prospective, openlabel, multicenter study, 128 de novo kidney transplant patients receiving cyclosporine (CsA) and steroids were randomized to an intensified regimen of enteric-coated mycophenolate sodium (EC-MPS) or to a standard EC-MPS regimen to Week 6 posttransplant, after which the regimen was identical. In a follow-up study to Month 12 post-transplant (49 intensified regimen, 52 standard regimen), the reduced rate of BPAR observed at Month 6 (intensified regimen 3.2%, standard regimen 16.9%, p = 0.016) was maintained at Month 12 (4.8% vs. 18.5%, p = 0.026). Estimated GFR (Cockcroft-Gault) at Month 12 was comparable in the intensified group (mean (SD) 54.8 (22.9) ml/min) vs. the standard group (mean (SD) 57.5 (23.6) ml/min, p = 0.83). The incidence of adverse events and serious adverse events at Month 12 was similar in both treatment groups, although adverse events with a suspected relation to study drug were reported in 69.8% and 50.8% of patients in the intensified and standard regimen groups, respectively (p = 0.032). Infections and hematological parameters were similar between groups. In conclusion, an early regimen of intensified EC-MPS with CsA and steroids achieves a low rate of BPAR over the first year after kidney transplantation with similar renal function to a standard regimen, and without a clinically relevant impact on safety. | ||
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| 650 | 4 | |a Aged | |
| 650 | 4 | |a Cyclosporine | |
| 650 | 4 | |a Female | |
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| 650 | 4 | |a Germany | |
| 650 | 4 | |a Glomerular Filtration Rate | |
| 650 | 4 | |a Glucocorticoids | |
| 650 | 4 | |a Graft Rejection | |
| 650 | 4 | |a Graft Survival | |
| 650 | 4 | |a Humans | |
| 650 | 4 | |a Immunosuppressive Agents | |
| 650 | 4 | |a Kidney Transplantation | |
| 650 | 4 | |a Male | |
| 650 | 4 | |a Middle Aged | |
| 650 | 4 | |a Mycophenolic Acid | |
| 650 | 4 | |a Prospective Studies | |
| 650 | 4 | |a Tablets, Enteric-Coated | |
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