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®.
Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.
Brief Title
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Kidney Transplant Rejection
Eligibility 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
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
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03326076
Org Class
Industry
Org Full Name
CareDx
Org Study Id
KOAR
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
Primary Outcomes
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
Outcome Time Frame
Feb-2020
Outcome Measure
Total number of biopsies planned and performed post-transplant, including both surveillance and clinically indicated biopsies
Outcome Time Frame
Feb-2020
Secondary Outcomes
Outcome Description
Evaluated at one-year post-transplant, quantified by biopsy-based histopathology grade(s)
Outcome Time Frame
Dec-2022
Outcome Measure
Transplant glomerulopathy (TG)
Outcome Description
Evaluated at years 1, 2, and 3 post-transplant
Outcome Time Frame
Dec-2022
Outcome Measure
Patient and graft survival
Outcome Description
Evaluated at years 1, 2, and 3 post-transplant
Outcome Time Frame
Dec-2022
Outcome Measure
Serum creatinine
Outcome Description
Evaluated at years 1, 2, and 3 post-transplant
Outcome Time Frame
Dec-2022
Outcome Measure
Estimated glomerular filtration rate
Outcome Time Frame
Dec-2022
Outcome Measure
Sensitivity of AlloSure for active rejection
Outcome Time Frame
Dec-2022
Outcome Measure
Specificity of AlloSure for active rejection
Outcome Time Frame
Dec-2022
Outcome Measure
Negative Predictive Value (NPV) of AlloSure for active rejection
Outcome Time Frame
Dec-2022
Outcome Measure
Positive Predictive Value (PPV) of AlloSure for active rejection
Outcome Time Frame
Dec-2022
Outcome Measure
Develop and validate the clinical use of KidneyCare®
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Maria Ajaimy
Investigator Email
majaimy@montefiore.org
Investigator Phone
347-949-1780