A randomized trial of intensified vs. standard dosing for enteric-coated mycophenolate sodium in de novo kidney transplant recipients

• Verfasst von: Arns, Wolfgang [VerfasserIn]
• Verfasst von: Sommerer, Claudia [VerfasserIn]
• Verfasst von: Glander, Petra [VerfasserIn]
• Verfasst von: Ariatabar, Toofan [VerfasserIn]
• Verfasst von: Porstner, Martina [VerfasserIn]
• Verfasst von: May, Christoph [VerfasserIn]
• Verfasst von: Paulus, Eva-Maria [VerfasserIn]
• Verfasst von: Shipkova, Maria [VerfasserIn]
• Verfasst von: Fischer, Wolfgang [VerfasserIn]
• Verfasst von: Liefeldt, Lutz [VerfasserIn]
• Verfasst von: Hackenberg, Ruth [VerfasserIn]
• Verfasst von: Schemmer, Peter [VerfasserIn]
• Verfasst von: Domhan, Sophie [VerfasserIn]
• Verfasst von: Zeier, Martin [VerfasserIn]
• Verfasst von: Budde, Klemens [VerfasserIn]
• Titel: A randomized trial of intensified vs. standard dosing for enteric-coated mycophenolate sodium in de novo kidney transplant recipients
• Titelzusatz: results at 1 year
• Verf.angabe: 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
• Jahr: 2013
• Umfang: 11 S.
• Fussnoten: Gesehen am 26.10.2020
• Titel Quelle: Enthalten in: Clinical nephrology
• Ort Quelle: Deisenhofen, Munich : Dustri-Verl. Feistle, 2002
• Jahr Quelle: 2013
• Band/Heft Quelle: 79(2013), 6, Seite 421-431
• DOI: doi:10.5414/CN107908
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Adult
• Sach-SW: Aged
• Sach-SW: Cyclosporine
• Sach-SW: Female
• Sach-SW: Follow-Up Studies
• Sach-SW: Germany
• Sach-SW: Glomerular Filtration Rate
• Sach-SW: Glucocorticoids
• Sach-SW: Graft Rejection
• Sach-SW: Graft Survival
• Sach-SW: Humans
• Sach-SW: Immunosuppressive Agents
• Sach-SW: Kidney Transplantation
• Sach-SW: Male
• Sach-SW: Middle Aged
• Sach-SW: Mycophenolic Acid
• Sach-SW: Prospective Studies
• Sach-SW: Tablets, Enteric-Coated
• Sach-SW: Treatment Outcome
• K10plus-PPN: 1736601237

Abstract

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.