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)
Public ClinicalTrials.gov record NCT00683553. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I, Randomized, Double-Blind, Dose Escalation Trial of the Safety and Pharmacokinetics of a Single Intravenous Injection of I5NP in Patients at High Risk of Acute Kidney Injury Undergoing Major Cardiovascular Surgery
Study identification
- NCT ID
- NCT00683553
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Quark Pharmaceuticals
- Industry
- Enrollment
- 3 participants
Conditions and interventions
Conditions
Interventions
- I5NP Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 21 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2008
- Primary completion
- Apr 30, 2010
- Completion
- Aug 31, 2010
- Last update posted
- Nov 15, 2010
2008 – 2010
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| George Washington University | Washington D.C. | District of Columbia | 20037 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Texas Heart Institute | Houston | Texas | 77030 | — |
| The Methodist Hospital | Houston | Texas | 77030 | — |
| University of Texas | Houston | Texas | 77030 | — |
| University of Virginia School of Medicine | Charlottesville | Virginia | 22908-0688 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00683553, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 15, 2010 · Synced Jun 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00683553 live on ClinicalTrials.gov.