Steroid-Withdrawal at 3 Days After Renal Transplantation with Anti-IL-2 Receptor α Therapy: A Prospective, Randomized, Multicenter Study

Abstract

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-2Ra 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.

Steroid Minimization in Pediatric Renal Transplantation

“…The feasibility of complete avoidance of steroids in adults after renal transplantation was first suggested by an open label Canadian multicenter trial [5]. Since then, reports from other centers have also confirmed the efficacy and safety of various steroid minimization or avoidance regimens in adults [6][7][8][9]. These studies have also provided evidence that renal allograft recipients managed with less steroid exposure experience benefits such as a lower incidence of hypertension, diabetes, weight gain and hyperlipidemia.…”

Defining a Steroid Withdrawal Protocol in a newly established Kidney Transplantation Unit

“…At 12 months the study revealed no difference in AR confi rmed by biopsy between daclizumab group (15%) and control group (14%) [23]. The survival of grafts in the 2 groups was not different at 12 months [2,36].…”

Untitled

“…It was concluded that, with daclizumab induction, it was possible to withdraw steroids at 3 days after RT. 61 A meta-analysis of 9 randomized control trials (1820 participants) assessed the effects of steroid withdrawal between 3 and 6 months after RT in patients on CNI plus MMF. Use of cyclosporine was associated with an increased incidence of BPAR (RR = 1.61).…”