This trial was designed to determine the most appropriate dosing strategy for the Phase III program in kidney transplantation. The primary efficacy objective of this trial was to demonstrate non-inferiority in biopsy proven acute rejection (BPAR) in de novo kidney transplant patients receiving voclosporin as compared to tacrolimus at six months. This objective was achieved and non-inferiority was established for each of the three voclosporin treatment groups.
A statistically lower incidence of new onset diabetes mellitus (NODM) at six months post transplantation was observed in the low dose voclosporin group compared to the tacrolimus group (1.6% versus 16.4%, respectively). Although not statistically different, the incidence of NODM was also noted to be lower in the mid-dose voclosporin group compared to the tacrolimus group (5.7% versus 16.4%, respectively).
Robert Foster, Isotechnika’s chairman and CEO, said: “Promise has shown that the efficacy of voclosporin is statistically non-inferior when compared to the market leader, tacrolimus in all three dose groups. While matching tacrolimus in efficacy, key safety advantages such as a lower incidence of NODM and preservation of kidney function were shown.”