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A Dose Escalation and Safety Study of I5NP in Patients Undergoing Major Cardiovascular Surgery

Study:

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

Rationale:

n/a

Purpose:

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

Recruiting:
n/a

Condition Intervention Phase
Injury of Kidney
Acute Renal Failure
Drug: I5NP (a small interfering RNA)
Drug: placebo
Phase 1

Verified by Quark Pharmaceuticals February, 2011

Sponsored by: Quark Pharmaceuticals
Information provided by: Quark Pharmaceuticals
ClinicalTrials.gov identifier: NCT00554359

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
United States

Martin S. Polinsky, M.D.., Study Director

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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