Kidney Transplant RejectionKOARNCT03326076
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
An observational study of Kidney Transplant Rejection, run by CareDx at 72 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Donor-derived cell-free DNA (AlloSure®), Peripheral blood gene expression profiling (AlloMap Kidney) and Analytic platform (IBox)
- How many people
- 4,000 participants
- Where
- 72 sitesUnited States
- Study dates
- 23 Jan 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
KOAR Inclusion Criteria:
- 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 Exclusion Criteria:
___________________________________________________________
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
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
United States72 sites
Augusta University
Augusta, Georgia, 30912
University of Colorado Hospital
Aurora, Colorado, 80045
University of Colorado- Anschutz Medical Campus
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02144
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Erie County Medical Center
Buffalo, New York, 14215
Medical University of South Carolina
Charleston, South Carolina, 29425
Metrolina Nephrology Associates
Charlotte, North Carolina, 28207
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The University of Missouri
Columbia, Missouri, 65212
Ohio State University Medical Center
Columbus, Ohio, 43210
UT Southwestern
Dallas, Texas, 75390
Geisinger Clinic
Danville, Pennsylvania, 17822-4033
Duke University
Durham, North Carolina, 22705
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Baylor All Saints Medical Center
Fort Worth, Texas, 76104
Texas Research Institute
Fort Worth, Texas, 76104
East Carolina University/Vidant Medical Center
Greenville, North Carolina, 27834
Houston Methodist Hospital
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky Chandler Hospital
Lexington, Kentucky, 40536
Saint Barnabus Medical Center
Livingston, New Jersey, 07039
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
Loyola University
Maywood, Illinois, 60153
Methodist Healthcare Foundation
Memphis, Tennessee, 38104
University of Miami/Jackson Memorial Hospital
Miami, Florida, 33136
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Intermountain Medical Center
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37292
Yale University
New Haven, Connecticut, 06519
Tulane University Medical Center
New Orleans, Louisiana, 70112
Ochsner Foundation Hospital
New Orleans, Louisiana, 70121
The Oklahoma Transplant Center at OU Medical Center
Oklahoma City, Oklahoma, 73104
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
University of Nebraska Medical Center
Omaha, Nebraska, 68105
AdventHealth
Orlando, Florida, 32804
Stanford Health Care
Palo Alto, California, 94304
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
Virginia Commonwealth University
Richmond, Virginia, 23298
UC Davis Medical Center
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84132
UT Health San Antonio
San Antonio, Texas, 78229
California Pacific Medical Center
San Francisco, California, 94115
University of California San Francisco
San Francisco, California, 94143
University of Washington Medical Center
Seattle, Washington, 98195
Willis-Knighton Physician Network/ John C. McDonald Regional Transplant Center
Shreveport, Louisiana, 71103
Sacred Heart Medical Center
Spokane, Washington, 99204
Washington University (Barnes Jewish Hospital)
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Baylor Scott & White Medical Center
Temple, Texas, 76508
Montefiore Medical Center
The Bronx, New York, 10467
Georgetown University
Washington D.C., District of Columbia, 20007
George Washington University
Washington D.C., District of Columbia, 20037
Cleveland Clinic - Weston
Weston, Florida, 33331
Wake Forest Baptist Medical Center- Department of General Surgery
Winston-Salem, North Carolina, 27157
About this study
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®.
Read the 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.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Donor-derived cell-free DNA (AlloSure®), Standard care, Peripheral blood gene expression profiling (AlloMap Kidney), Analytic platform (IBox)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor-derived cell-free DNA (AlloSure®)Diagnostic test
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 careOther
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)Diagnostic test
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)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary donor-derived cell-free DNA | 300 patients with planned renal surveillance biopsies at 12 months post-transplantation Receives: Diagnostic Test: Donor-derived cell-free DNA (AlloSure®) | |
| 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 Receives: Other: Standard care | |
| Secondary donor-derived cell-free DNA | 1200 patients without planned renal surveillance biopsies at 12 months post-transplantation Receives: Diagnostic Test: Donor-derived cell-free DNA (AlloSure®) | |
| Primary KidneyCare® | 300 patients with planned renal surveillance biopsies at 12 months post-transplantation Receives: Diagnostic Test: Donor-derived cell-free DNA (AlloSure®); Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney); Diagnostic Test: Analytic platform (IBox) | |
| Secondary KidneyCare® | 1200 patients without planned renal surveillance biopsies at 12 months post-transplantation Receives: Diagnostic Test: Donor-derived cell-free DNA (AlloSure®); Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney); Diagnostic Test: Analytic platform (IBox) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Feb-2020
Total number of biopsies planned and performed post-transplant, including both surveillance and clinically indicated biopsies
Measured: Feb-2020
Secondary outcomes (9)
Transplant glomerulopathy (TG)
Evaluated at one-year post-transplant, quantified by biopsy-based histopathology grade(s)
Measured: Dec-2022
Patient and graft survival
Evaluated at years 1, 2, and 3 post-transplant
Measured: Dec-2022
Serum creatinine
Evaluated at years 1, 2, and 3 post-transplant
Measured: Dec-2022
Estimated glomerular filtration rate
Evaluated at years 1, 2, and 3 post-transplant
Measured: Dec-2022
Sensitivity of AlloSure for active rejection
Measured: Dec-2022
Specificity of AlloSure for active rejection
Measured: Dec-2022
Negative Predictive Value (NPV) of AlloSure for active rejection
Measured: Dec-2022
Positive Predictive Value (PPV) of AlloSure for active rejection
Measured: Dec-2022
Develop and validate the clinical use of KidneyCare®
Measured: Dec-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start23 Jan 2018
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CareDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326076
- Sponsor's protocol ID
- KOAR
- Acronym
- KOAR
- Status last verified
- Jun 2023
- First submitted
- 24 Oct 2017
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28280140Grskovic 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.
PubMed 27727019Klein JA, Taber D, Wojciechowski D, Mandelbrot DA, Glehn-Ponsirenas R, Olaitan O, Jain P, Lu J, McGrath MM, Narayanan M, Patel AM, Merzkani M, Permpalung N, Choudhury RA, Josephson MA, Anand S, Vaitla P, Langewisch E, Ajaimy M, Kumar D, Burke GW 3rd, Pesavento TE, Langone AJ, Huang Y, Leeser D, Fischbach B, Costa N, Sureshkumar K, Qannus AA, Fan CS, Zaky Z, Shihab F, Kulkarni S, Maw TT, Tanriover B, Akalin E, Cooper M, Tawhari I, Weir MR, Alhamad T, Brennan DC, Leca N, Bunnapradist S, Shen L, Woodward RN, Chuang P, Anand P, Poggio ED, Guerra G, Wiseman A, Paramesh A, Cibrik D, Bromberg J; KOAR Study Investigators. Elevations in Donor-Derived Cell-Free DNA and Allograft Outcomes in Kidney Transplantation. J Am Soc Nephrol. 2026 Jun 16. doi: 10.1681/ASN.0000001133. Online ahead of print.
PubMed 42302101
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
- ClinicalTrials.gov ID
- NCT03326076
- Acronym / sponsor ID
- KOAR / KOAR
- Conditions
- Kidney Transplant Rejection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- CareDxIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Primary donor-derived cell-free DNA | – | Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)300 patients with planned renal surveillance biopsies at 12 months post-transplantation |
| Control | – | Other: Standard careA 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 | – | Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)1200 patients without planned renal surveillance biopsies at 12 months post-transplantation |
| Primary KidneyCare® | – | Diagnostic Test: Donor-derived cell-free DNA (AlloSure®), Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney), Diagnostic Test: Analytic platform (IBox)300 patients with planned renal surveillance biopsies at 12 months post-transplantation |
| Secondary KidneyCare® | – | Diagnostic Test: Donor-derived cell-free DNA (AlloSure®), Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney), Diagnostic Test: Analytic platform (IBox)1200 patients without planned renal surveillance biopsies at 12 months post-transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Primary KidneyCare®, Primary donor-derived cell-free DNA, Secondary KidneyCare®, Secondary donor-derived cell-free DNA |
| Standard careCurrent standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy) | Other | Control |
| 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. | Diagnostic test | Primary KidneyCare®, Secondary KidneyCare® |
| 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. | Diagnostic test | Primary KidneyCare®, Secondary KidneyCare® |
Primary outcome
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
Time frame: Feb-2020
Total number of biopsies planned and performed post-transplant, including both surveillance and clinically indicated biopsies
Time frame: Feb-2020
9 secondary outcomes
Transplant glomerulopathy (TG)
Time frame: Dec-2022
Patient and graft survival
Time frame: Dec-2022
Serum creatinine
Time frame: Dec-2022
Estimated glomerular filtration rate
Time frame: Dec-2022
Sensitivity of AlloSure for active rejection
Time frame: Dec-2022
Specificity of AlloSure for active rejection
Time frame: Dec-2022
Negative Predictive Value (NPV) of AlloSure for active rejection
Time frame: Dec-2022
Positive Predictive Value (PPV) of AlloSure for active rejection
Time frame: Dec-2022
Develop and validate the clinical use of KidneyCare®
Time frame: Dec-2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Background: PubMed 28280140Bloom 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.
- Background: PubMed 27727019Grskovic 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.
- Derived from this study: PubMed 42302101Klein JA, Taber D, Wojciechowski D, Mandelbrot DA, Glehn-Ponsirenas R, Olaitan O, Jain P, Lu J, McGrath MM, Narayanan M, Patel AM, Merzkani M, Permpalung N, Choudhury RA, Josephson MA, Anand S, Vaitla P, Langewisch E, Ajaimy M, Kumar D, Burke GW 3rd, Pesavento TE, Langone AJ, Huang Y, Leeser D, Fischbach B, Costa N, Sureshkumar K, Qannus AA, Fan CS, Zaky Z, Shihab F, Kulkarni S, Maw TT, Tanriover B, Akalin E, Cooper M, Tawhari I, Weir MR, Alhamad T, Brennan DC, Leca N, Bunnapradist S, Shen L, Woodward RN, Chuang P, Anand P, Poggio ED, Guerra G, Wiseman A, Paramesh A, Cibrik D, Bromberg J; KOAR Study Investigators. Elevations in Donor-Derived Cell-Free DNA and Allograft Outcomes in Kidney Transplantation. J Am Soc Nephrol. 2026 Jun 16. doi: 10.1681/ASN.0000001133. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
72 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection, run by CareDx at 72 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Feb-2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326076, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.