BTS Report 2014: 5-year outcomes of a randomized prospective trial (CamTac Trial)

Poster Presentation:  Study of alemtuzumab induction with tacrolimus maintenance monotherapy compared to IL2R blockade with tacrolimus/MMF maintenance in kidney transplantation by Adam McLean, Imperial College Kidney & Transplant Centre, London.

The CamTac trial has provided evidence that a minimalist immunosuppressive regimen of alemtuzumab induction with early (day 7) steroid cessation followed by low-dose tacrolimus maintenance monotherapy is associated with long-term clinical outcomes that are comparable to those achieved with a regimen of IL2R monoclonal (daclizumab) induction with early steroid cessation and tacrolimus/MMF combination maintenance therapy. The patients included in the CamTac trial have now reached five years of follow-up. Adam McLean, who was one of the investigators in the CamTac trial, presented the results of the five-year analysis.

The CamTac study originally included 82 patients randomised to the test arm (A) and 41 patients randomised to the control arm (D). Two patients in the test arm had moved abroad since the study and follow-up and outcome data were thus available on 98.5% of patients. At five years, no significant difference between the two arms could be detected with respect to any of the outcomes patient survival (92.1% in arm A vs 94.7% in arm D; p=NS), death-censored graft survival (88.8% vs 85.0%; p=NS), or survival with functioning graft (81.3% vs 80.5%, p=NS), indicating that the two treatment regimens remained comparable with overall favourable outcomes over a medium-term time span. The investigators also noted that the incidence of rejection had become increasingly similar in the two groups – analyses at 12 months and at three-year follow-up had shown a non-significant trend towards higher rejection rates in arm D, but this trend was no longer evident at five years. The investigators concluded that the outcomes of a minimalist approach involving alemtuzumab induction with low-dose tacrolimus maintenance therapy remain closely comparable to those associated with a more conventional immunosuppressive regimen.