Acute rejection characteristics from a prospective, randomized, double-blind, placebo-controlled multicenter trial of early corticosteroid withdrawal.
Gaber AO, Moore LW, et al.Transplantation 2013; 95(4): 573-579.
Aims
To investigate and report acute rejection and rejection outcomes in renal transplant patients on continuous corticosteroid therapy or early corticosteroid withdrawal from the Astellas Blinded CSWD Trial database.
Interventions
Participants in the trial were randomized to receive either corticosteroid therapy or corticosteroid withdrawal.
Participants
386 kidney transplant recipients.
Outcomes
The primary outcomes included: time to event analysis of death, graft loss, and incidence of moderate to severe biopsy confirmed acute rejection requiring antilymphocyte antibody therapy. Secondary rejection related outcomes included patient and graft survival, frequency, severity and treatment of acute rejection.
Follow-up
5 years.
CET Conclusions
This paper reports the five-year follow up of a corticosteroid withdrawal trial in kidney transplantation. At the five-year point there was no difference in the composite end-point (death, graft-loss, incidence of moderate to severe acute rejection). Episodes of rejection, including borderline changes, were more common in the withdrawal group. The difference in rates of acute rejection was apparent only in the non-African-American subgroup. There was no change in acute rejection rates in African-Americans. The difference in rates of acute rejection was also apparent in deceased donor transplants in the longer-term follow up, but not in the first 3-month, as it was in live donor transplants.
Data analysis
Modified intention-to-treat analysis
Quality notes
Previously assessed Woodle ES, First MR et al. A prospective, randomized, double-blind, placebo-controlled multicenter trial comparing early (7 day) corticosteroid cessation versus long-term, low-dose corticosteroid therapy. Annals of Surgery 2008;248:564.
Trial registration
ClinicalTrials.gov – NCT00650468