Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
Public ClinicalTrials.gov record NCT03326076. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.
Study identification
- NCT ID
- NCT03326076
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 4,000 participants
Conditions and interventions
Conditions
Interventions
- Donor-derived cell-free DNA (AlloSure®) Diagnostic Test
- Standard care Other
- Peripheral blood gene expression profiling (AlloMap Kidney) Diagnostic Test
- Analytic platform (IBox) Diagnostic Test
Diagnostic Test · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 23, 2018 (Actual)
- Primary completion
- Jun 30, 2025 (Estimated)
- Completion
- Dec 31, 2025 (Estimated)
- Last update posted
- Jun 27, 2023
2018 – 2025
United States locations
- U.S. sites
- 72
- U.S. states
- 31
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Loma Linda Medical Center | Loma Linda | California | 92354 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90043 | — |
| University of Southern California | Los Angeles | California | 90089 | — |
| University of California, Los Angeles | Los Angeles | California | 90095 | — |
| Stanford Health Care | Palo Alto | California | 94304 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| University of Colorado- Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Yale University | New Haven | Connecticut | 06519 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| George Washington University | Washington D.C. | District of Columbia | 20037 | — |
| University of Miami/Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| AdventHealth | Orlando | Florida | 32804 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Cleveland Clinic - Weston | Weston | Florida | 33331 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Loyola University | Maywood | Illinois | 60153 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Kentucky Chandler Hospital | Lexington | Kentucky | 40536 | — |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | — |
| Ochsner Foundation Hospital | New Orleans | Louisiana | 70121 | — |
| Willis-Knighton Physician Network/ John C. McDonald Regional Transplant Center | Shreveport | Louisiana | 71103 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University | Baltimore | Maryland | 21205 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02144 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| The University of Missouri | Columbia | Missouri | 65212 | — |
| Washington University (Barnes Jewish Hospital) | St Louis | Missouri | 63110 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | — |
| Saint Barnabus Medical Center | Livingston | New Jersey | 07039 | — |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Erie County Medical Center | Buffalo | New York | 14215 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Metrolina Nephrology Associates | Charlotte | North Carolina | 28207 | — |
| Duke University | Durham | North Carolina | 22705 | — |
| East Carolina University/Vidant Medical Center | Greenville | North Carolina | 27834 | — |
| Wake Forest Baptist Medical Center- Department of General Surgery | Winston-Salem | North Carolina | 27157 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| The Oklahoma Transplant Center at OU Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| Geisinger Clinic | Danville | Pennsylvania | 17822-4033 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Methodist Healthcare Foundation | Memphis | Tennessee | 38104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37292 | — |
| UT Southwestern | Dallas | Texas | 75390 | — |
| Baylor All Saints Medical Center | Fort Worth | Texas | 76104 | — |
| Texas Research Institute | Fort Worth | Texas | 76104 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| UT Health San Antonio | San Antonio | Texas | 78229 | — |
| Baylor Scott & White Medical Center | Temple | Texas | 76508 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
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 NCT03326076, 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 Jun 27, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03326076 live on ClinicalTrials.gov.