Kidney Disease Marta Crespo and Clara Barrios

Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation

Primary Objectives:

To determine the safety and dose-limiting toxicities of I5NP when administered as a single slow intravenous push (IVP) to patients undergoing deceased donor kidney transplant.
To obtain an exploratory estimate of the effects of I5NP on DGF.

Study Design:

The study is conducted in two parts. The first part was a randomized, dose escalation study (Part A) to determine the maximum tolerated dose (MTD), already performed in the United States. The safety profile appeared consistent with that of deceased donor recipients during the early post-Tx period. These safety data supported continued evaluation of this drug for prophylaxis of delayed graft function in deceased donor transplantation. The second part (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.