In:
Journal of Transplantation, Hindawi Limited, Vol. 2014 ( 2014), p. 1-8
Abstract:
In a six-month, multicenter, open-label trial, de novo kidney transplant recipients at low immunological risk were randomized to steroid avoidance or steroid withdrawal with IL-2 receptor antibody (IL-2RA) induction, enteric-coated mycophenolate sodium (EC-MPS: 2160 mg/day to week 6, 1440 mg/day thereafter), and cyclosporine. Results from a 30-month observational follow-up study are presented. Of 166 patients who completed the core study on treatment, 131 entered the follow-up study (70 steroid avoidance, 61 steroid withdrawal). The primary efficacy endpoint of treatment failure (clinical biopsy-proven acute rejection (BPAR) graft loss, death, or loss to follow-up) occurred in 21.4% (95% CI 11.8–31.0%) of steroid avoidance patients and 16.4% (95% CI 7.1–25.7%) of steroid withdrawal patients by month 36 ( P = 0.46 ). BPAR had occurred in 20.0% and 11.5%, respectively ( P = 0.19 ). The incidence of adverse events with a suspected relation to steroids during months 6–36 was 22.9% versus 37.1% ( P = 0.062 ). By month 36, 32.4% and 51.7% of patients in the steroid avoidance and steroid withdrawal groups, respectively, were receiving oral steroids. In conclusion, IL-2RA induction with early intensified EC-MPS dosing and CNI therapy in de novo kidney transplant patients at low immunological risk may achieve similar three-year efficacy regardless of whether oral steroids are withheld for at least three months.
Type of Medium:
Online Resource
ISSN:
2090-0007
,
2090-0015
Language:
English
Publisher:
Hindawi Limited
Publication Date:
2014
detail.hit.zdb_id:
2503421-2
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