CLINICAL IMMUNOSUPPRESSION - KIDNEY EARLY

W. Arns¹, M. Zeier², P. Glander³, T. Ariatabar¹, S. Kramer⁴, E. Vogel⁴, C. Sommerer², K. Budde^3
1, Transplantationszentrum, Koeln-Merheim/GERMANY, ², Nierenzentrum, Heidelberg/GERMANY, ³, University Hospital Charité, Berlin/GERMANY, ⁴, Novartis Pharma, Nuremberg/GERMANY

Body:
Purpose: We examined the influence of an intensified dosing (ID) regimen with enteric-coated mycophenolate sodium (EC-MPS) in comparison to EC-MPS standard dosing (SD) on efficacy and safety 12 months after renal transplantation
Methods: De-novo kidney transplant recipients were treated with basiliximab, steroids and cyclosporine and randomized to EC-MPS SD (1440mg/d) or to an intensified EC-MPS dosing regimen (ID: 2 weeks: 2880 mg/d; subsequent 4 weeks: 2160 mg/d; followed by 1440 mg/d). After completion of the core study at month 6, patients were included in an observational follow-up until month 12.
Results: 128 patients were randomized to either SD (n=65) or ID (n=63), 101 (78.9%) pts (n=49 ID vs. n=52 SD) completed the follow-up analysis at month 12. Patient survival was 98.0% in the ID and 96.2% in the SD group, and 3 graft losses were observed in the ID and 5 graft losses in the SD group The incidence of BPAR was lower in the intensified compared to the standard group (SD n=12 (23%) vs. ID n=3 (6.1%); p= 0.025) from transplantation to month 12 with one additional BPAR in ID vs 2 BPAR in SD pts in the follow-up period. In the follow-up period (month 6 to month 12) the ID regimen was not associated with a higher rate of hematological side effects (11 ID pts vs. 15 SD pts) with comparable hemoglobin values (Median: 12.80 g/dl ID vs. 12.75 g/dl SD) and similar number of leucocytes (Median: 7.2 /nl ID vs. 7.5 /nl SD). Slightly more infections (29 ID pts vs. 24 SD pts) and gastrointestinal symptoms (19 ID pts vs. 15 SD pts) were reported in the ID group. BKV infection was detected in 4 vs. 2 patients and CMV infections in 4 vs. 1 patients, respectively (ID vs. SD).
Conclusion: An intensified dosing regimen of EC-MPS was associated with a significantly lower BPAR rate after 12 months without compromising tolerability and safety.

Disclosure: All authors have declared no conflicts of interest.