5-Year outcomes of the prospective and randomized cistcert study comparing steroid withdrawal to replacement of cyclosporine with everolimus in de novo kidney transplant patients.
Pipeleers, L., et al.Transplant International 2020 [record in progress].
Aims
The aim of this study was to report the 5-year outcomes of the CISTERT study, a randomised controlled trial that compared the safety and efficacy of steroid withdrawal versus replacement of cyclosporine with everolimus at 3-months post-transplant, in de novo renal transplant recipients.
Interventions
Participants were randomised to switch to either steroid withdrawal or replace cyclosporine by everolimus at 3-months following transplantation.
Participants
151 de novo kidney transplant patients.
Outcomes
The outcomes of interest included the assessment of glomerular filtration rate (GFR) at one year following transplantation, graft survival, patient survival, malignancies, infections, rejection episodes, diabetes, proteinuria and cardiovascular morbidity.
Follow-up
5 years
CET Conclusions
This paper reports 5-year outcomes of the CISTERT study, which compared conversion from CNI to everolimus with steroid withdrawal strategies from 3-months post-transplant. The results are as one would expect from the two strategies – a slight improvement in GFR in patients who were able to tolerate everolimus, but with higher incidence of new-onset diabetes and rejection compared to the steroid withdrawal (and CNI continuation) arm. Graft and patient survival were excellent and similar in both arms. It is good to see investigators publishing long-term results from RCTs. As with many mTOR studies, treatment was poorly tolerated and the difference in GFR was absent in the modified intent-to-treat analysis. The study is likely underpowered as a number of patients originally randomised to everolimus failed to convert, and only 36-37% patients remained on the randomised treatment for the full 5 years of follow-up.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov number - NCT00903188; EudraCT Number 2007-005844-26