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Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry (KOAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326076
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
CareDx

Study Description
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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®.


Condition or disease Intervention/treatment
Kidney Transplant Rejection Diagnostic Test: Donor-derived cell-free DNA (AlloSure®) Other: Standard care Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney) Diagnostic Test: Analytic platform (IBox)

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
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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
Primary donor-derived cell-free DNA
300 patients with planned renal surveillance biopsies at 12 months post-transplantation
 Diagnostic Test: 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
 Other: 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
 Diagnostic Test: 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
 Diagnostic Test: 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: 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: 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
 Diagnostic Test: 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: 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: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Total number of biopsies planned and performed post-transplant, including both surveillance and clinically indicated biopsies [ Time Frame: Feb-2020 ]

Secondary Outcome Measures :
  1. Transplant glomerulopathy (TG) [ Time Frame: Dec-2022 ]
    Evaluated at one-year post-transplant, quantified by biopsy-based histopathology grade(s)

  2. Patient and graft survival [ Time Frame: Dec-2022 ]
    Evaluated at years 1, 2, and 3 post-transplant

  3. Serum creatinine [ Time Frame: Dec-2022 ]
    Evaluated at years 1, 2, and 3 post-transplant

  4. Estimated glomerular filtration rate [ Time Frame: Dec-2022 ]
    Evaluated at years 1, 2, and 3 post-transplant

  5. Sensitivity of AlloSure for active rejection [ Time Frame: Dec-2022 ]
  6. Specificity of AlloSure for active rejection [ Time Frame: Dec-2022 ]
  7. Negative Predictive Value (NPV) of AlloSure for active rejection [ Time Frame: Dec-2022 ]
  8. Positive Predictive Value (PPV) of AlloSure for active rejection [ Time Frame: Dec-2022 ]
  9. Develop and validate the clinical use of KidneyCare® [ Time Frame: Dec-2022 ]

Biospecimen Retention:   Samples With DNA
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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

KOAR Inclusion Criteria:

  1. 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.
  2. 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:

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326076


Contacts
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Contact: Sham Dholakia 415-287-2374 sdholakia@caredx.com
Contact: Alana Burns 415-287-2420 aburns@caredx.com

Locations
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Sponsors and Collaborators
CareDx
More Information
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Publications:

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Responsible Party: CareDx
ClinicalTrials.gov Identifier: NCT03326076    
Other Study ID Numbers: KOAR
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No