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)
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Acute Renal Failure, Acute Kidney Injury
In brief
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.
Key facts
- Study ID
- NCT00683553
- Run by
- Quark Pharmaceuticals
- People needed
- 3
- Starts
- 2008-05-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2010-11-16
Who can join
Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Mayo Clinic Hospital — Phoenix, Arizona, United States
- George Washington University — Washington D.C., District of Columbia, United States
- Washington University — St Louis, Missouri, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Texas Heart Institute — Houston, Texas, United States
- The Methodist Hospital — Houston, Texas, United States
- University of Texas — Houston, Texas, United States
- University of Virginia School of Medicine — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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