Sirolimus vs cyclosporine after induction with basiliximab does not promote regulatory t cell expansion in de novo kidney transplantation: Results from a single-center randomized trial.
Libetta C, Esposito P, et al.Transplant Immunology 2015 Oct;33(2):117-24
Aims
To evaluate the effects of induction therapy with basiliximab followed by maintenance treatment with Sirolimus (SRL) or cyclosporine (CsA) on Regulatory T-cell (Treg) count and renal tissue infiltration in de novo renal transplant recipients.
Interventions
All patients were initially treated with basiliximab, steroids, CsA and mycophenolate mofetil (MMF). One month after transplantation patients were randomised to either the SRL group and received SRL in combination with methylprednisolone (MP) and MMF, or to the CsA group and received CsA, MP and MMF
Participants
62 first-time recipients of a deceased donor kidney aged 18-70 years
Outcomes
The primary outcome was the impact of induction therapy on circulating Treg number. Secondary outcomes were the quantification of renal tissue infiltration and the relationship between Treg count and clinical outcomes.
Follow-up
2 years
CET Conclusions
This is an interesting study of Treg cells in recipients of deceased donor kidneys. All patients were induced with basiliximab and then received CSA for 1 month before randomisation to continue CSA or switch to sirolimus. All patients received MMF and prednisolone. Treg cells were defined asCD4+CD25+FoxP3+ and CD127-.The patients were followed for 2 years and no difference was observed in the levels of Treg cells or renal function in the two groups, although it was noted that there was a significant drop in Treg cells in both groups at 1 month after transplantation, presumably due to the induction with basiliximab.. Protocol biopsies did not show any difference in FoxP3 cells in the infiltrate between the two groups. Thus this is an important addition to the literature on the relevance of Treg cells in human organ transplantation, which is becoming more confusing to say the least!
Data analysis
Modified intention-to-treat analysis
Trial registration
Clinicaltrials.gov - NCT01014234