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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00037470 | Other Identifier | Advarra IRB |
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| Name | Class |
|---|---|
| University of Maryland | OTHER |
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The ProActive registry is a longitudinal, multi-center study with a prospective arm observing clinical care for patients receiving physician ordered Prospera, an allograft rejection test, and a historical control arm collecting data on cases at the same sites whose kidney allograft rejection status was managed with Serum Creatinine SCr/estimated Glomerular Filtration Rate eGFR. This registry will compare patient management and outcomes in patients who receive Prospera (Prospera arm) to the outcomes of the historical control group (control arm) to determine Prospera's clinical utility. High-risk subjects defined as having a biopsy-demonstrated rejection event or at least one pre-existing Donor Specific Antibody DSA with total Mean Fluorescent Intensity MFI>3000 or a calculated Panel Reactive Antibodies cPRA>70% will be followed for an additional period up to 24 months in both the Prospera arm and historical control arm.
The primary objective is to differentiate the clinical utility of Prospera testing from the use of creatinine testing as measured by the proportion of positive biopsies in post renal allograft patients.
Secondary objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospera Arm | There is no intervention in this study. Adult patients who have received a kidney allograft from a genetically different donor in the past 2 years including within 60 days and who have been selected by their healthcare provider to receive Prospera dd-cfDNA testing according to their regular interval testing schedule as part of their clinical care will have medical records pertaining to their kidney rejection status collected at each study visit. |
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| Control Arm | The control arm will consist of retrospective data review of cases where a renal allograft from a genetically different donor was performed. Data pertaining to to their kidney rejection status from a minimum of 3 time points per year post allograft (up to 5 years) or until renal allograft failure will be collected. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospera | Diagnostic Test | No Interventions, this is an observational study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficiency of biopsies | The proportion of clinically indicated biopsies that show Active Rejection (AR) will be measured in the Prospera arm and the control arm. Specifically, the proportion of clinically indicated biopsies showing AR in individuals with a positive donor derived-cell free DNA dd-cfDNA test at the time of Bx in the test arm, where Prospera has been integrated into the care paradigm, will be compared against the proportion of clinically indicated biopsies showing AR in the control arm. | 3 years |
| Graft function | Graft function in the Prospera arm and control arm will be measured. This will be assessed by examining the average eGFR score (as calculated using serum creatinine Chronic Kidney Disease-EPIdemiology collaboration CKD_EPI equation) at year three in the Prospera arm compared to the average eGFR score determined at year three in the historical control arm. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the performance of Prospera | The performance of Prospera to detect AR will be evaluated. The sensitivity, specificity, Positive & Negative Predictive Value of the assay in sub-cohorts of patients will be calculated and compared to the performance of serum creatinine to detect AR in those cohorts. | 5 years |
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Inclusion Criteria Prospera Arm:
Exclusion Criteria Prospera Arm:
Inclusion Criteria Control Arm:
Exclusion Criteria Control Arm:
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Approximately 5,000 adult renal allograft participants will be enrolled in this study, and data will be collected from a de-identified cohort of approximately 500 historical control patients who had a renal allograft.
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Bromberg, MD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Arizona Kidney Disease & Hypertension Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38595232 | Derived | Bromberg JS, Bunnapradist S, Samaniego-Picota M, Anand S, Stites E, Gauthier P, Demko Z, Prewett A, Armer-Cabral M, Marshall K, Kaur N, Bloom MS, Tabriziani H, Bhorade S, Cooper M; ProActive Investigators. Elevation of Donor-derived Cell-free DNA Before Biopsy-proven Rejection in Kidney Transplant. Transplantation. 2024 Sep 1;108(9):1994-2004. doi: 10.1097/TP.0000000000005007. Epub 2024 Aug 20. |
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There are two arms to this study: A prospective arm and a historical control (retrospective arm).
Each participant in the Prospective arm will have received the commercially available Prospera test.
Subjects prospectively enrolled and whom consent to "Optional future Research" may have bio-specimens stored for future research.
The historical arm (retrospective cohort) will not have any bio-specimens collected or stored.
| Evaluate whether Prospera can detect acute rejection earlier than serum creatinine |
The grade of rejection observed in biopsies in the Prospera arm will be compared to the historical control arm which used serum creatinine. |
| 3 years |
| Determine if and how Prospera testing impacts patient care | The proportion of Prospera assay results that doctors felt influenced their decisions around management of patients and biopsies will be calculated. This will be analyzed separately for the for-cause and protocol biopsies. | 5 years |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Arizona Kidney Disease & Hypertension Centers | Scottsdale | Arizona | 85258 | United States |
| Arizona Kidney Disease and Hypertension Centers | Tucson | Arizona | 85712 | United States |
| Arizona Kidney Disease & Hypertension Centers | Tucson | Arizona | 85718 | United States |
| Banner University Medical Center | Tucson | Arizona | 85719 | United States |
| University of California Davis Medical Center | Davis | California | 95616 | United States |
| University of California, Irvine | Irvine | California | 92697 | United States |
| Keck School of Medicine USC | Los Angeles | California | 90033 | United States |
| The Regents of the University of California on behalf of its Los Angeles campus | Los Angeles | California | 90095 | United States |
| Riverside Community Hospital | Riverside | California | 92501 | United States |
| California Institute of Renal Research | San Diego | California | 92123 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Yale University, School of Medicine | New Haven | Connecticut | 06520 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20057 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| Florida Health Sciences Center | Tampa | Florida | 33606 | United States |
| Cleveland Clinic Florida (Weston) | Weston | Florida | 33331 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| The University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Renal Transplant Associates of New England | Springfield | Massachusetts | 01107 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Harper University Hospital, Detroit Medical Center, Wayne State University | Detroit | Michigan | 48201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| St. Louis University | St Louis | Missouri | 63103 | United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | United States |
| University of Nebraska | Omaha | Nebraska | 68198 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| Northwell Health, Inc | Manhasset | New York | 11030 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| The Research Institute at Westchester Medical Center | Valhalla | New York | 10595 | United States |
| East Carolina University | Greenville | North Carolina | 27858 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The University of Toledo | Toledo | Ohio | 43606 | United States |
| Legacy Research | Portland | Oregon | 97232 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Kidney Care Specialists | Bethlehem | Pennsylvania | 18017 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Vanderbilt University | Nashville | Tennessee | 37235 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Baylor Scott and White Research Institute | Temple | Texas | 76508 | United States |
| IHC Health Services, Inc | Salt Lake City | Utah | 84111 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |