A Dose Escalation and Safety Study of I5NP to Prevent Acute Kidney Injury (AKI) in Patients at High Risk of AKI Undergoing Major Cardiovascular Surgery (QRK.004)
- Conditions
- Acute Renal FailureAcute Kidney Injury
- Interventions
- Drug: Placebo
- Registration Number
- NCT00683553
- Lead Sponsor
- Quark Pharmaceuticals
- Brief Summary
This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic study. The study will be conducted in approximately 10 sites in the United States. Up to 48 patients at high risk for AKI (CCF score ≥ 5 OR an estimated GFR (eGFR) \<60 mL/min/1.73 m2) 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 - 5 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.
- Detailed Description
The drug (I5NP) is a small interfering RNA that is being developed to protect patients from acute kidney injury after cardiac bypass surgery. This study will test the safety of I5NP and measure how long the drug stays in the blood stream after injection. This study is not meant to test if I5NP protects kidneys from the damage that may occur in rare cases during surgery. Another purpose of this dose escalation study is to find out the right dose of the experimental drug to be given to study subjects in future studies. Even though there were no harmful effects seen in the animals tested, we do not know what side effects the experimental drug might cause in humans.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Placebo I5NP - I5NP drug I5NP -
- Primary Outcome Measures
Name Time Method Number of Dose Limiting Toxicities (DLTs) observed among 4 cohorts of 6-12 patients per cohort Reviewed at the conclusion of each cohort Pharmacokinetics Immediately following injection through 24 hrs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
University of Virginia School of Medicine
🇺🇸Charlottesville, Virginia, United States
University of Texas
🇺🇸Houston, Texas, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Washington University
🇺🇸St. Louis, Missouri, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States