Multicentre, multi-arm, double-blind randomised placebo-controlled dose-finding trial investigating the safety and Efficacy of MirococePt (APT070) In Reducing delayed graft function In the Kidney ALlograft (EMPIRIKAL-2): study protocol for a randomised controlled trial.

10 20 The results with the first dose (10 mg, infused into the donor organ), however, showed no effect on DGF rate compared with the control group (although there was an encouraging trend towards faster recovery of renal function associated with Mirococept in patients with immediate graft function (IGF).

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A Phase IIa pilot study in 16 kidney transplant patients confirmed the feasibility of the ex vivo administration of Mirococept at 10 mg/kidney prior to transplantation and showed a trend towards more rapid recovery of graft function compared with control organs. 21 The first EMPIRIKAL Phase II study set out to evaluate the dose and efficacy of Mirococept in reducing DGF rates in deceased donor kidney transplantation. 22 The design was to test a dose range of 5–25 mg in cohorts of 80 patients for each dose with a maximum number of seven cohorts.

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