Transplant Trial Watch

Early Corticosteroid Cessation vs Long-term Corticosteroid Therapy in Kidney Transplant Recipients: Long-term Outcomes of a Randomized Clinical Trial.

Woodle, E. S., et al.

JAMA Surgery 2021 [record in progress].


Aims
The aim of this study was to investigate the long-term outcomes of early corticosteroid cessation versus corticosteroid therapy continuation in recipients of kidney transplant.

Interventions
Patients were randomised to either early corticosteroid withdrawal or to continue maintenance corticosteroids following transplantation.

Participants
397 kidney transplant recipients.

Outcomes
The main outcomes were graft loss (death-censored and non-censored for death), patient death, and moderate to severe short-term rejection following transplantation.

Follow-up
5 years

CET Conclusions
This paper reports long-term registry follow-up of patients included in a randomised controlled trial of early (day 7) corticosteroid withdrawal versus maintenance in renal transplant recipients. With median follow-up of over 15 years, no differences were seen in hazard for graft failure or mortality, leading the authors to conclude that maintenance steroids are not required for successful transplant outcomes, despite an increase in early steroid sensitive acute rejection episodes. This report is a great example of the power of using registry data to obtain efficient long-term follow-up of patients from randomised controlled trials. There are obvious limitations to the approach – the analysis is limited to survival outcomes and unable to look at differences in cardiac endpoints, for example – but nonetheless the approach should be used more widely.

Trial registration
N/A

Funding source
Industry funded