QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
Public ClinicalTrials.gov record NCT03510897. 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 Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.
Study identification
- NCT ID
- NCT03510897
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,043 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jun 28, 2018
- Primary completion
- Oct 13, 2020
- Completion
- Apr 11, 2021
- Last update posted
- Jul 15, 2021
2018 – 2021
United States locations
- U.S. sites
- 36
- U.S. states
- 23
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35294 | — |
| Keck Hospital of USC | Los Angeles | California | 90033 | — |
| Cedar-Sinai Heart Institute | Los Angeles | California | 90048 | — |
| Ronald Regan UCLA Medical Center | Los Angeles | California | 90095 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| River City Clinical Research | Jacksonville | Florida | 32207 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| Northwestern University | Evanston | Illinois | 60208 | — |
| Indiana/ Ohio Heart, a division of Luthern Medical Group, LLC | Fort Wayne | Indiana | 46804 | — |
| Indiana University Health-Methodist Hospital | Indianapolis | Indiana | 46202 | — |
| University of Kentucky Healthcare | Lexington | Kentucky | 40536 | — |
| University of Louisville Physicians (ULP) | Louisville | Kentucky | 40202 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| MidMichigan Medical Center Midland | Midland | Michigan | 48670 | — |
| Cardiac & Vascular Research Center of Northern Michigan | Petoskey | Michigan | 49770 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Bryan Heart | Lincoln | Nebraska | 68506 | — |
| Nebraska Heart Hospital | Lincoln | Nebraska | 68526 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Mission Hospital, Inc. | Asheville | North Carolina | 28801 | — |
| Duke University Hospital Medical Center | Durham | North Carolina | 27710 | — |
| East Carolina Heart Institute at East Carolina University | Greenville | North Carolina | 27834 | — |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Baylor Jack and Jane Hamilton Heart and Vascular Hospital - Soltero Cardiovasular | Dallas | Texas | 75246 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| University of Utah Health | Salt Lake City | Utah | 84132 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | — |
| University Hospital | Madison | Wisconsin | 53792 | — |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 68 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03510897, 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 Jul 15, 2021 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03510897 live on ClinicalTrials.gov.