A randomized trial of intensified vs. standard dosing for enteric-coated mycophenolate sodium in de novo kidney transplant recipients : results at 1 year / 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

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..

Medienart:

E-Artikel

Erscheinungsjahr:

2013

Erschienen:

2013

Enthalten in:

Zur Gesamtaufnahme - volume:79

Enthalten in:

Clinical nephrology - 79(2013), 6, Seite 421-431

Sprache:

Englisch

Beteiligte Personen:

Arns, Wolfgang [VerfasserIn]
Sommerer, Claudia, 1971- [VerfasserIn]
Glander, Petra [VerfasserIn]
Ariatabar, Toofan [VerfasserIn]
Porstner, Martina [VerfasserIn]
May, Christoph [VerfasserIn]
Paulus, Eva-Maria [VerfasserIn]
Shipkova, Maria [VerfasserIn]
Fischer, Wolfgang [VerfasserIn]
Liefeldt, Lutz [VerfasserIn]
Hackenberg, Ruth [VerfasserIn]
Schemmer, Peter, 1967- [VerfasserIn]
Domhan, Sophie, 1976- [VerfasserIn]
Zeier, Martin [VerfasserIn]
Budde, Klemens [VerfasserIn]

Links:

Volltext [lizenzpflichtig]

Themen:

Adult
Aged
Cyclosporine
Female
Follow-Up Studies
Germany
Glomerular Filtration Rate
Glucocorticoids
Graft Rejection
Graft Survival
Humans
Immunosuppressive Agents
Kidney Transplantation
Male
Middle Aged
Mycophenolic Acid
Prospective Studies
Tablets, Enteric-Coated
Treatment Outcome

Anmerkungen:

Gesehen am 26.10.2020

Umfang:

11

doi:

10.5414/CN107908

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

1736601237

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