A Phase I, Randomized, Double-Blind, Dose Escalation Trial of the Safety and Pharmacokinetics of a Single Intravenous Injection of I5NP in Patients Undergoing Major Cardiovascular Surgery
This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic
study. The study will be conducted in approximately 8-10 centers in the United States and
Switzerland. Up to 32 patients who have undergone major cardiovascular surgery will
participate. Patients will receive a single IV injection of I5NP or placebo following
cardiovascular surgery. I5NP will be administered 4 hours (+/- 30 minutes) following removal
of the cardiopulmonary bypass machine (CBM).
The duration of the study is approximately 44 days, inclusive of a 14 day screening period.
Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient
visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 and Day 7 or hospital
discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls will be
made at 6 and 12 months after date of surgery.
Study Status: Completed
Injury of Kidney
Acute Renal Failure
Drug: I5NP (a small interfering RNA)
Information provided by:
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Cleveland Clinic Foundation
Cleveland, Ohio 44195
Martin S. Polinsky, M.D.., Study Director