Delayed Graft Function Clinical Trial
Official title:
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
The purpose of this study is to determine whether a single administration of QPI-1002 (also
known as 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.
Although the etiology of DGF is not fully understood and may be multifactorial, the
pathophysiology appears to be primarily related to ischemia-reperfusion (IR) injury
resulting from organ preservation between the times of harvesting from the donor and
reperfusion following vascular reanastomosis in the recipient.
I5NP is a small interfering RNA (siRNA) that is being developed for the prophylaxis of
delayed graft function (DGF) in patients receiving renal transplants.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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