Randomized Trial of Dual Antibody Induction Therapy with Steroid Avoidance in Renal Transplantation.
Ciancio G, Gaynor JJ, et al.Transplantation, 92(12): 1348-1357, 2011.
Aims
To compare the outcomes of two dual antibody induction therapies, anti-thymocyte globulin (ATG) and daclizumab versus ATG and alemtuzumab with steroid avoidance in renal transplantation.
Interventions
ATG and daclizumab versus ATG and alemtuzumab. Maintenance immunosupression was low dose tacrolimus, enteric-coated mycophenolate sodium (MPS) and early corticosteroid withdrawal.
Participants
200 primary kidney transplant recipients.
Outcomes
Primary endpoint was the incidence of first biopsy proven acute rejection (BPAR) at 12 months posttransplant. Other outcomes were patients and graft survival, renal function measured as creatinine and estimated glomerular filtration rate. Adverse events included rate of new onset diabetes mellitus (NODM) and infections.
Follow-up
48 months.
CET Conclusions
No difference was found in BPAR rates, patient or graft survival and renal function with a follow up approaching 4 years. There was a low rate of NODM in both groups and infections were equally low in both groups. Thus both these dual induction therapies with reduced dose tacrolimus and enteric coated MPS with early steroid withdrawal resulted in a favourable outcome. It is also worthy of note that some 70% of patients were Hispanic or African American.
Data analysis
Strict intention-to-treat analysis
Trial registration
Not reported