Early Steroid Withdrawal in Recipients of a Kidney Transplant From a Living Donor: Experience of a Single Mexican Center.
Andrade-Sierra J, Rojas-Campos E, et al.Transplantation Proceedings 2016; 48(1): 42-49.
Aims
To evaluate the effects of early steroid withdrawal (ESW) on the frequency and severity of acute rejection (AR) in renal transplant patients.
Interventions
All participants received basiliximab, tacrolimus and MMF, and were randomised to receive immunosuppressive maintenance conducted without prednisone (PDN) (ESW group), or with PDN (Control group).
Participants
71 renal transplant recipients from a living donor, aged >18 years of age with a panel reactive antibody (PRA) class I and II HLA <20%.
Outcomes
The primary outcome measured was the incidence of acute rejection. Other outcomes measured were patient and graft survival, renal function, hypertension, blood pressure, proteinuria, tacrolimus serum levels, hypercholesterolemia, weight and body mass index.
Follow-up
12 months
CET Conclusions
This small single-centre open label trial investigates the effects of early steroid withdrawal (day 5 post-transplant) in a low-risk live-donor renal transplant population. Compared to maintenance steroids, no differences are seen in acute rejection rates or patient or graft survival. Renal function, measured by eGFR, was significantly better in the steroid withdrawal group, with lower blood pressure and less antihypertensive use. Given the small sample size, open-label nature and low-risk population, this trial does not add much new to the knowledge gained from previous larger trials and meta-analyses. The study is dramatically underpowered to detect a difference in the primary endpoint of acute rejection. The authors present a power calculation suggesting that 20 patients per group would provide adequate power to detect a 13% difference in acute rejection. Rejection rate in the control arm was 15%. Even taking the presented 13% difference in acute rejection as a non-inferiority margin (which would assume that a rejection rate of up to 27% was not inferior!), a non-inferiority study would require a sample size of 188 patients.
Data analysis
Per protocol analysis
Trial registration
None