Immunophenotyping and efficacy of low dose ATG in non-sensitized kidney recipients undergoing early steroid withdrawal: a randomized pilot study.

PLoS ONE. 2014; 9(8):e104408.

Aims
To compare the efficacy and immunophenotyping of low dosage rabbit antithymocyte globulin (ATG) regimens in low immunological risk kidney transplant recipients.

Interventions
Patients were administered with a standard dose of ATG (1.25mg/kg x 3 doses) or low dose of ATG (0.75mg/kg x 3 doses). All patients received tacrolimus, mycophenolate mofetil and a seven day corticosteroid taper.

Participants
45 patients scheduled for a living or deceased donor renal transplant.

Outcomes
The primary outcome was the incidence of biopsy proven acute rejection. The secondary outcomes included patient survival, graft survival, serum creatinine levels, incidence of infection, leukopenia and cancers.

Follow-up
15 months (mean).

CET Conclusions
This small, non-blinded study compares two low-dose rATG induction regimens in low-risk renal transplant recipients. “Standard dosing” is 3.75mg/kg split over 3 days, “Low dosing” is 2.25 mg/kg over 3 days. All patients underwent a rapid steroid taper (7 days) and received tacrolimus and MMF maintenance immunosuppression. The authors found little difference between the two protocols, either in clinical outcomes (survival, function, rejection) or in T-cell kinetics. Whilst they have suggested that a low-dose regimen is safe in low-risk, non-sensitised recipients, it should be noted that this is described as a “pilot” study and is likely underpowered to confirm this conclusion. The authors suggest that this reduction in ATG dose could save $3,000 per patient. As they rightly point out, both basiliximab and alemtuzumab are cheaper still, so one would have to compare the efficacy of reduced-dose ATG to these cheaper agents in a similar low risk population to truly determine the most cost-effective strategy.

Jadad score
3

Data analysis
Modified intention-to-treat analysis

Allocation concealment
No

Trial registration
ClinicalTrials.gov – NCT01280617

Funding source
Non-industry funded