A Randomized, Multicenter Study of Steroid Avoidance, Early Steroid Withdrawal or Standard Steroid Therapy in Kidney Transplant Recipients

Abstract

In a randomized, open-label, multicenter study, de novo renal transplant patients received no steroids (n = 112), steroids to day 7 (n = 115), or standard steroids (n = 109) with cyclosporine microemulsion (CsA-ME), enteric-coated mycophenolate sodium (EC-MPS) and basiliximab. The primary objective, to demonstrate noninferiority of 12-month GFR in the steroid-free or steroid-withdrawal groups versus standard steroids, was not met in the intent-to-treat population. However, investigational groups were not inferior to standard steroids in the observed-case analysis. Median 12-month GFR was not significantly different in the steroid-free or steroid-withdrawal groups (58.6 mL/min/1.73 m 2 and 59.1 mL/min/1.73 m 2 ) versus standard steroids (60.8 mL/min/1.73 m 2 ). The 12-month incidence of biopsy-proven acute rejection (BPAR), graft loss or death was 36.0% in the steroidfree group (p = 0.007 vs. standard steroids), 29.6% with steroid withdrawal (N.S.) and 19.3% with standard steroids. BPAR was significantly less frequent with standard steroids than either of the other two regimens. Reduced de novo use of antidiabetic and lipidlowering medication, triglycerides and weight gain were observed in one or both steroid-minimization group versus standard steroids. For standard-risk renal transplant patients receiving CsA-ME, EC-MPS and † See Acknowledgements. basiliximab, steroid withdrawal by the end of week 1 achieves similar 1-year renal function to a standardsteroids regimen, and may be more desirable than complete steroid avoidance.

New-Onset Diabetes After Transplantation:Results From a Double-Blind Early Corticosteroid Withdrawal Trial

“…However, corticosteroid weaning was only started approximately 450 days after transplantation, and NODAT was reported in only 10/118 (8.5%) of patients (16). In the FREEDOM study, recipients were randomized to steroids, no steroids, or steroids to day 7 with maintenance therapy consisting of cyclosporine, mycophenolate sodium and basiliximab induction (17). The de novo use of hypoglycemic agents was less in the steroid-free group (4.5%) compared to the steroid withdrawal (12.2%) or standard steroid group (14.7%).…”

Cardiovascular risk factors following renal transplant

“…Reduction or withdrawal of corti costeroids can reduce the risk of developing post transplant diabetes and may actually reverse it and restore insulin sensitivity [76] . One study has compared complete steroid avoidance with early withdrawal after one week and standard steroid administration [77] . They found that, after one year, the incidence of post Neale J et al .…”

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

“…Patient and graft survival rates remained the same in all study groups at 12 months review point [7,31].…”