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AlloSure for the Monitoring of Antibody Mediated Processes After Kidney Transplantation

NCT04057742 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2024-09-03

No results posted yet for this study

Summary

This is a prospective cohort observational study to assess the role of AlloSure Donor Derived Cell Free DNA (ddcfDNA) assay in the monitoring of three high-risk groups of kidney transplant patients for antibody mediated processes.

* Group A. Thirty participants with a positive Virtual Cross-Match (VXM) at the time of transplant will be monitored for 12 months
* Group B. Similarly, 24 participants with dnDSA will undergo a SOC biopsy within approximately three months to determine the incidence of Active Antibody Mediated Rejection (AMR)
* Group C. 15 additional participants with the diagnosis of Chronic Active Antibody Mediated Rejection (cAMR) will undergo standard of care therapy and be monitored for treatment response with a follow-up biopsy at three months

Conditions

  • Kidney Transplant Failure and Rejection

Interventions

DIAGNOSTIC_TEST

AlloSure ddcfDNA assay

2.5 mL collection for Donor Derived Cell Free DNA at transplant, 3 weeks, 6 weeks, 6 months, 12 months post-transplant for Group A, at transplant for Group B, and transplant and 3 months for Group C

DIAGNOSTIC_TEST

AlloMap assay

10 mL collection PAXgene blood sample at transplant, 3 weeks, 6 weeks, 6 months, 12 months post-transplant for Group A, at transplant for Group B, and transplant and 3 months for Group C

DIAGNOSTIC_TEST

Inflammatory Cytokines

10 mL collection at transplant, 3 weeks, 6 weeks, 6 months, 12 months post-transplant for Group A

DIAGNOSTIC_TEST

Immune Cell Phenotypes

Collection of up to 1 cup of urine for per participant each study visit

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • CareDx

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Sarah Panzer, MD · University of Wisconsin, Madison

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2024-04-07
Completion
2024-04-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057742 on ClinicalTrials.gov