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Steroid‐Withdrawal at 3 Days After Renal Transplantation with Anti‐IL‐2 Receptor α Therapy: A Prospective, Randomized, Multicenter Study
Author(s) -
Meulen Cornelis G. ter,
Riemsdijk Iza van,
Hené Ronald J.,
Christiaans Maarten H. L.,
Borm George F.,
Gelder Teun van,
Hilbrands Luuk B.,
Weimar Willem,
Hoitsma Andries J.
Publication year - 2004
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/j.1600-6143.2004.00419.x
Subject(s) - daclizumab , medicine , tacrolimus , transplantation , prednisolone , kidney transplantation , urology , immunosuppression , regimen , surgery , randomized controlled trial , gastroenterology
Steroids have been included in most immunosuppressive regimens after renal transplantation, but are feared for their side‐effects. We conducted a prospective multicenter study to investigate whether it is feasible to withdraw steroids early after transplantation with the use of anti‐IL‐2Rα induction, tacrolimus and mycophenolate mofetil (MMF). A total of 364 patients were randomized to receive either two doses of daclizumab (1 mg/kg) and, for the first 3 days, 100 mg of prednisolone (daclizumab group n = 186), or steroids (tapered to 0 mg at week 16; controls n = 178). All patients received tacrolimus and MMF. The incidence of biopsy‐confirmed acute rejection at 12 months was not different between the daclizumab group (15%) and the controls (14%) (95% confidence interval of difference: −6 to + 8%, NS). Graft survival at 12 months was comparable in the two groups (daclizumab group: 91%; controls: 90%). Mean arterial blood pressure, serum lipids, and incidence of patients with hyperglycemia were temporary lower in the daclizumab group compared with controls. The immunosuppressive regimen of the daclizumab group was associated with increased costs. In conclusion, with the use of anti‐IL‐2Ra induction and daily therapy with tacrolimus and MMF it is feasible to withdraw steroids at 3 days after renal transplantation.