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Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

Active, not recruiting
Conditions
Kidney Transplant Rejection
Registration Number
NCT03326076
Lead Sponsor
CareDx
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®.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
4000
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 patientsFeb-2020
Total number of biopsies planned and performed post-transplant, including both surveillance and clinically indicated biopsiesFeb-2020
Secondary Outcome Measures
NameTimeMethod
Patient and graft survivalDec-2022

Evaluated at years 1, 2, and 3 post-transplant

Serum creatinineDec-2022

Evaluated at years 1, 2, and 3 post-transplant

Estimated glomerular filtration rateDec-2022

Evaluated at years 1, 2, and 3 post-transplant

Sensitivity of AlloSure for active rejectionDec-2022
Transplant glomerulopathy (TG)Dec-2022

Evaluated at one-year post-transplant, quantified by biopsy-based histopathology grade(s)

Specificity of AlloSure for active rejectionDec-2022
Negative Predictive Value (NPV) of AlloSure for active rejectionDec-2022
Positive Predictive Value (PPV) of AlloSure for active rejectionDec-2022
Develop and validate the clinical use of KidneyCare®Dec-2022

Trial Locations

Locations (72)

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

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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
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