Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Arns, W; Sommerer, C; Glander, P; Ariatabar, T; Porstner, M; May, C; Paulus, EM; Shipkova, M; Fischer, W; Liefeldt, L; Hackenberg, R; Schemmer, P; Domhan, S; Zeier, M; Budde, K.
A randomized trial of intensified vs. standard dosing for enteric-coated mycophenolate sodium in de novo kidney transplant recipients: results at 1 year.
Clin Nephrol. 2013; 79(6):421-431
Doi: 10.5414/CN107908
Web of Science
PubMed
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- Co-authors Med Uni Graz
- Schemmer Peter
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- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Cyclosporine - administration & dosage
- Cyclosporine - adverse effects
- Female -
- Follow-Up Studies -
- Follow-Up Studies -
- Glomerular Filtration Rate -
- Glucocorticoids - administration & dosage
- Glucocorticoids - adverse effects
- Graft Rejection - prevention & control
- Graft Survival - drug effects
- Humans -
- Immunosuppressive Agents - administration & dosage
- Immunosuppressive Agents - adverse effects
- Kidney Transplantation - methods
- Male -
- Middle Aged -
- Mycophenolic Acid - administration & dosage
- Mycophenolic Acid - adverse effects
- Mycophenolic Acid - analogs & derivatives
- Prospective Studies -
- Tablets, Enteric-Coated -
- Treatment Outcome -
- Find related publications in this database (Keywords)
- mycophenolic acid
- MPA
- EC-MPS
- intensified
- efficacy