Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
KOAR
1 other identifier
observational
4,000
1 country
72
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 30, 2017
CompletedStudy Start
First participant enrolled
January 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 27, 2023
June 1, 2023
7.4 years
October 24, 2017
June 23, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (9)
Transplant glomerulopathy (TG)
Dec-2022
Patient and graft survival
Dec-2022
Serum creatinine
Dec-2022
Estimated glomerular filtration rate
Dec-2022
Sensitivity of AlloSure for active rejection
Dec-2022
- +4 more secondary outcomes
Study Arms (5)
Primary donor-derived cell-free DNA
300 patients with planned renal surveillance biopsies at 12 months post-transplantation
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
Secondary donor-derived cell-free DNA
1200 patients without planned renal surveillance biopsies at 12 months post-transplantation
Primary KidneyCare®
300 patients with planned renal surveillance biopsies at 12 months post-transplantation
Secondary KidneyCare®
1200 patients without planned renal surveillance biopsies at 12 months post-transplantation
Interventions
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.
Current standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy)
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.
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
All eligible renal transplant recipients who meet the inclusion/exclusion criteria will be a part of this observational study. The control cohort will include the patients cared for without the use of AlloSure® or KidneyCare at the participating centers who received their transplant in the 6 months prior to the enrollment start for the primary cohort.
You may qualify if:
- 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.
You may not qualify if:
- \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CareDxlead
Study Sites (72)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Loma Linda Medical Center
Loma Linda, California, 92354, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90043, United States
University of Southern California
Los Angeles, California, 90089, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Stanford Health Care
Palo Alto, California, 94304, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of California San Francisco
San Francisco, California, 94143, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
University of Colorado- Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06519, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
University of Miami/Jackson Memorial Hospital
Miami, Florida, 33136, United States
AdventHealth
Orlando, Florida, 32804, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Cleveland Clinic - Weston
Weston, Florida, 33331, United States
Augusta University
Augusta, Georgia, 30912, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Loyola University
Maywood, Illinois, 60153, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky Chandler Hospital
Lexington, Kentucky, 40536, United States
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
Ochsner Foundation Hospital
New Orleans, Louisiana, 70121, United States
Willis-Knighton Physician Network/ John C. McDonald Regional Transplant Center
Shreveport, Louisiana, 71103, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02144, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
The University of Missouri
Columbia, Missouri, 65212, United States
Washington University (Barnes Jewish Hospital)
St Louis, Missouri, 63110, United States
Washington University
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105, United States
Saint Barnabus Medical Center
Livingston, New Jersey, 07039, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Erie County Medical Center
Buffalo, New York, 14215, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Metrolina Nephrology Associates
Charlotte, North Carolina, 28207, United States
Duke University
Durham, North Carolina, 22705, United States
East Carolina University/Vidant Medical Center
Greenville, North Carolina, 27834, United States
Wake Forest Baptist Medical Center- Department of General Surgery
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
The Oklahoma Transplant Center at OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Geisinger Clinic
Danville, Pennsylvania, 17822-4033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Methodist Healthcare Foundation
Memphis, Tennessee, 38104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37292, United States
UT Southwestern
Dallas, Texas, 75390, United States
Baylor All Saints Medical Center
Fort Worth, Texas, 76104, United States
Texas Research Institute
Fort Worth, Texas, 76104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
Baylor Scott & White Medical Center
Temple, Texas, 76508, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Related Publications (2)
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.
PMID: 28280140BACKGROUNDGrskovic 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.
PMID: 27727019BACKGROUND
Biospecimen
Plasma from venous blood will be collected and cell-free DNA will be extracted from the plasma for analysis of donor-derived cell-free DNA
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2017
First Posted
October 30, 2017
Study Start
January 23, 2018
Primary Completion
June 30, 2025
Study Completion
December 31, 2025
Last Updated
June 27, 2023
Record last verified: 2023-06