Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
NCT ID: NCT03326076
Last Updated: 2023-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
4000 participants
OBSERVATIONAL
2018-01-23
2025-12-31
Brief Summary
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Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary donor-derived cell-free DNA
300 patients with planned renal surveillance biopsies at 12 months post-transplantation
Donor-derived cell-free DNA (AlloSure®)
Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Control
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
Standard care
Current standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy)
Secondary donor-derived cell-free DNA
1200 patients without planned renal surveillance biopsies at 12 months post-transplantation
Donor-derived cell-free DNA (AlloSure®)
Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Primary KidneyCare®
300 patients with planned renal surveillance biopsies at 12 months post-transplantation
Donor-derived cell-free DNA (AlloSure®)
Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Peripheral blood gene expression profiling (AlloMap Kidney)
Patients will receive peripheral blood gene expression profiling testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Analytic platform (IBox)
Patients will receive IBox testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Secondary KidneyCare®
1200 patients without planned renal surveillance biopsies at 12 months post-transplantation
Donor-derived cell-free DNA (AlloSure®)
Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Peripheral blood gene expression profiling (AlloMap Kidney)
Patients will receive peripheral blood gene expression profiling testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Analytic platform (IBox)
Patients will receive IBox testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Interventions
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Donor-derived cell-free DNA (AlloSure®)
Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Standard care
Current standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy)
Peripheral blood gene expression profiling (AlloMap Kidney)
Patients will receive peripheral blood gene expression profiling testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Analytic platform (IBox)
Patients will receive IBox testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Eligibility Criteria
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Inclusion Criteria
2. Subjects willing to provide written informed consent to participate.
Exclusion Criteria
Exclusions for AlloSure® Intended Use
Specimens from patients for whom any of the following are true will not be tested:
1. Recipients of transplanted organs other than kidney
2. Recipients of a transplant from a monozygotic (identical)
3. Recipients of a bone marrow transplant
4. Recipients who are pregnant
5. Recipients who are under the age of 18
6. Recipient who are less than 14 days post-transplant
18 Years
ALL
Yes
Sponsors
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CareDx
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, 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
University of California, Los Angeles
Los Angeles, California, United States
Stanford Health Care
Palo Alto, California, 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
Yale University
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
George Washington University
Washington D.C., District of Columbia, United States
University of Miami/Jackson Memorial Hospital
Miami, Florida, United States
AdventHealth
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Cleveland Clinic - Weston
Weston, Florida, United States
Augusta University
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University
Maywood, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky Chandler Hospital
Lexington, Kentucky, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
Ochsner Foundation Hospital
New Orleans, Louisiana, United States
Willis-Knighton Physician Network/ John C. McDonald Regional Transplant Center
Shreveport, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
The University of Missouri
Columbia, Missouri, United States
Washington University (Barnes Jewish Hospital)
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Saint Barnabus Medical Center
Livingston, New Jersey, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Erie County Medical Center
Buffalo, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Metrolina Nephrology Associates
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
East Carolina University/Vidant Medical Center
Greenville, North Carolina, United States
Wake Forest Baptist Medical Center- Department of General Surgery
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
The Oklahoma Transplant Center at OU Medical Center
Oklahoma City, Oklahoma, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 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
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Methodist Healthcare Foundation
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern
Dallas, Texas, United States
Baylor All Saints Medical Center
Fort Worth, Texas, United States
Texas Research Institute
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
Baylor Scott & White Medical Center
Temple, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Countries
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References
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Bloom RD, Bromberg JS, Poggio ED, Bunnapradist S, Langone AJ, Sood P, Matas AJ, Mehta S, Mannon RB, Sharfuddin A, Fischbach B, Narayanan M, Jordan SC, Cohen D, Weir MR, Hiller D, Prasad P, Woodward RN, Grskovic M, Sninsky JJ, Yee JP, Brennan DC; Circulating Donor-Derived Cell-Free DNA in Blood for Diagnosing Active Rejection in Kidney Transplant Recipients (DART) Study Investigators. Cell-Free DNA and Active Rejection in Kidney Allografts. J Am Soc Nephrol. 2017 Jul;28(7):2221-2232. doi: 10.1681/ASN.2016091034. Epub 2017 Mar 9.
Grskovic M, Hiller DJ, Eubank LA, Sninsky JJ, Christopherson C, Collins JP, Thompson K, Song M, Wang YS, Ross D, Nelles MJ, Yee JP, Wilber JC, Crespo-Leiro MG, Scott SL, Woodward RN. Validation of a Clinical-Grade Assay to Measure Donor-Derived Cell-Free DNA in Solid Organ Transplant Recipients. J Mol Diagn. 2016 Nov;18(6):890-902. doi: 10.1016/j.jmoldx.2016.07.003. Epub 2016 Oct 7.
Other Identifiers
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KOAR
Identifier Type: -
Identifier Source: org_study_id
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