Late Conversion of Kidney Transplant Recipients from Ciclosporin to Tacrolimus Improves Graft Function: Results from a Randomized Controlled Trial.

PLoS ONE 2015; 10(8): e0135674.

Aims
To complete a secondary analysis of a Tacrolimus (TAC) to ciclosporin A (CSA) conversion study looking at graft function (eGFR) trajectories using linear mixed models.

Interventions
CSA treated patients were randomized to receive 0.1 mg/kg/day TAC (target 5–8 ng/ml) or to continue CSA (target 70–150 ng/ml) based immunosuppression.

Participants
141 long-term kidney transplant recipients with stable graft function

Outcomes
Primary outcomes measured were short and long term eGFR trajectories and trough levels. Other measured outcomes were graft function, cardiovascular disease risk factors, and safety parameters.

Follow-up
24 months

CET Conclusions
This manuscript reports a post-hoc medium-term analysis of patients converted from cyclosporine to tacrolimus at least 6 months after kidney transplantation. The authors use linear mixed modelling to study the trajectory of renal function (both baseline and slope of eGFR) to increase the statistical power over the original secondary endpoint of 24-month eGFR. The analysis demonstrates a significantly improved eGFR trajectory over 24 months, with an estimated difference of -4.48 ml/min at 24 months. Whilst this is statistically significant, the clinical significance is small and the post-hoc nature of the analysis should be noted. The CsA group also had a significantly higher age (62 vs 53 years) which may impact function, and it is not clear from the manuscript whether this variable was incorporated into the model.

Jadad score
3

Data analysis
Modified intention-to-treat analysis

Allocation concealment
No

Quality notes
Score based on 'Riegersperger M, et al. Effect of conversion from ciclosporin to tacrolimus on endothelial progenitor cells in stable long-term kidney transplant recipients. Transplantation 2013; 95(11):1338–45.'

Trial registration
EudraCT - 2004-004209-98; Clinicaltrials.gov - NCT00182559

Funding source
Industry funded