I5NP for Prophylaxis of Delayed Graft Function in Kidney Transplantation

The purpose of this study is to determine whether a single administration of I5NP can
prevent DGF in patients undergoing deceased donor kidney transplantation. In this Phase I
/II study, patients who are undergoing renal transplantation with organs from DCD donors,
ECD donors or SCD donors with ≥ 24 hours of cold ischemia time who meet study entry criteria
will be studied to evaluate the safety and pharmacokinetic profile of I5NP (Part A) and
clinical activity of I5NP administration (Part B). Data from this study will be used to
identify doses of I5NP to be used in follow-on efficacy studies.

Part A will be a randomized, dose escalation study to determine the highest or maximum
tolerated dose (MTD). Part A will enroll 40 patients at approximately 20 sites; patients
will be randomized to receive either I5NP or placebo in a ratio of 8:2 in each cohort
(cohorts 1-4).

Part B will utilize the dose identified in Part A to further evaluate, in a double-blind
manner, the safety, and clinical activity of I5NP. In Part B, up to 326 patients will
participate at approximately 60 sites; up to 163 patients will be randomized to receive I5NP
and up to 163 patients randomized to receive placebo.