Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
- Conditions
- Kidney Transplant Rejection
- Interventions
- Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)Other: Standard careDiagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney)Diagnostic Test: Analytic platform (IBox)
- Registration Number
- NCT03326076
- Lead Sponsor
- CareDx
- Brief Summary
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®.
- Detailed Description
The AlloSure test has been approved for Medicare coverage for clinical use when a physician determines there is a need to assess the probability of allograft rejection in kidney transplant recipients. The DART study suggests that use of the non-invasive AlloSure test to measure donor-derived cell-free DNA (dd-cfDNA) can be used to discriminate active rejection in a renal transplant recipient. Use of the test may reduce invasive percutaneous renal biopsy procedures among patients with a suspicion of rejection.
Amendment 1 (A1) is intended to enable the development of KidneyCare® which is a panel test which includes the clinically validated commercial AlloSure dd-cfDNA test, combined with AlloMap Kidney which is a peripheral blood gene expression profiling test currently under development, and iBox, which is an analytic platform that predicts allograft survival at 3, 5, 7 and 10 years using a proprietary software algorithm based on a number of clinical inputs. The AlloMap Kidney and the iBox components are not yet clinically validated and so will not be used for patient management and are being developed through this study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 4000
- Patient's health care provider adopts and intends to apply the center's AlloSure Routine Testing Schedule as part of the information used to manage the patient.
- Subjects willing to provide written informed consent to participate.
KOAR
Exclusions for AlloSure® Intended Use
Specimens from patients for whom any of the following are true will not be tested:
- Recipients of transplanted organs other than kidney
- Recipients of a transplant from a monozygotic (identical)
- Recipients of a bone marrow transplant
- Recipients who are pregnant
- Recipients who are under the age of 18
- Recipient who are less than 14 days post-transplant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Primary donor-derived cell-free DNA Donor-derived cell-free DNA (AlloSure®) 300 patients with planned renal surveillance biopsies at 12 months post-transplantation Control Standard care A matched control cohort of 1000 patients with planned renal surveillance biopsies at 12 months post-transplantation but were not managed with donor-derived cell-free DNA (AlloSure®) or KidneyCare will be retrospectively selected Primary KidneyCare® Analytic platform (IBox) 300 patients with planned renal surveillance biopsies at 12 months post-transplantation Secondary KidneyCare® Peripheral blood gene expression profiling (AlloMap Kidney) 1200 patients without planned renal surveillance biopsies at 12 months post-transplantation Primary KidneyCare® Peripheral blood gene expression profiling (AlloMap Kidney) 300 patients with planned renal surveillance biopsies at 12 months post-transplantation Secondary donor-derived cell-free DNA Donor-derived cell-free DNA (AlloSure®) 1200 patients without planned renal surveillance biopsies at 12 months post-transplantation Primary KidneyCare® Donor-derived cell-free DNA (AlloSure®) 300 patients with planned renal surveillance biopsies at 12 months post-transplantation Secondary KidneyCare® Donor-derived cell-free DNA (AlloSure®) 1200 patients without planned renal surveillance biopsies at 12 months post-transplantation Secondary KidneyCare® Analytic platform (IBox) 1200 patients without planned renal surveillance biopsies at 12 months post-transplantation
- Primary Outcome Measures
Name Time Method Interstitial fibrosis/tubular atrophy (IF/TA) quantified by Banff Working Group biopsy grade(s) at 12 months post-transplant in AlloSure® and renal allograft biopsy managed patients Feb-2020 Total number of biopsies planned and performed post-transplant, including both surveillance and clinically indicated biopsies Feb-2020
- Secondary Outcome Measures
Name Time Method Positive Predictive Value (PPV) of AlloSure for active rejection Dec-2022 Develop and validate the clinical use of KidneyCare® Dec-2022 Patient and graft survival Dec-2022 Evaluated at years 1, 2, and 3 post-transplant
Serum creatinine Dec-2022 Evaluated at years 1, 2, and 3 post-transplant
Estimated glomerular filtration rate Dec-2022 Evaluated at years 1, 2, and 3 post-transplant
Sensitivity of AlloSure for active rejection Dec-2022 Transplant glomerulopathy (TG) Dec-2022 Evaluated at one-year post-transplant, quantified by biopsy-based histopathology grade(s)
Specificity of AlloSure for active rejection Dec-2022 Negative Predictive Value (NPV) of AlloSure for active rejection Dec-2022
Trial Locations
- Locations (72)
East Carolina University/Vidant Medical Center
🇺🇸Greenville, North Carolina, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Ochsner Foundation Hospital
🇺🇸New Orleans, Louisiana, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Willis-Knighton Physician Network/ John C. McDonald Regional Transplant Center
🇺🇸Shreveport, Louisiana, United States
Augusta University
🇺🇸Augusta, Georgia, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Loma Linda Medical Center
🇺🇸Loma Linda, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Stanford Health Care
🇺🇸Palo Alto, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Saint Barnabus Medical Center
🇺🇸Livingston, New Jersey, United States
The University of Missouri
🇺🇸Columbia, Missouri, United States
University of Kentucky Chandler Hospital
🇺🇸Lexington, Kentucky, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Cleveland Clinic - Weston
🇺🇸Weston, Florida, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Loyola University
🇺🇸Maywood, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Erie County Medical Center
🇺🇸Buffalo, New York, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Metrolina Nephrology Associates
🇺🇸Charlotte, North Carolina, United States
Washington University (Barnes Jewish Hospital)
🇺🇸Saint Louis, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Methodist Healthcare Foundation
🇺🇸Memphis, Tennessee, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Baylor Scott & White Medical Center
🇺🇸Temple, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Baylor All Saints Medical Center
🇺🇸Fort Worth, Texas, United States
Texas Research Institute
🇺🇸Fort Worth, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
University of Colorado- Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
University of Miami/Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
AdventHealth
🇺🇸Orlando, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Duke University
🇺🇸Durham, North Carolina, United States
The Oklahoma Transplant Center at OU Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Wake Forest Baptist Medical Center- Department of General Surgery
🇺🇸Winston-Salem, North Carolina, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
UT Health San Antonio
🇺🇸San Antonio, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States