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Cf-DNA Assay During Treatment of Acute Rejection

NCT04019353 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2024-03-13

No results posted yet for this study

Summary

The objective of this study is to determine whether cell-free DNA (cf-DNA) measurement can be used as a biomarker for successful treatment of an acute rejection (AR) episode after kidney transplantation.

A fall in donor cf-DNA level may be a biomarker for successful AR treatment. The goal is to do an exploratory study to determine, in recipients with biopsy-proven AR, whether persistence or elevated levels of donor cf-DNA are associated with ongoing inflammation at the time of exit biopsy; and whether fall in donor cf-DNA level is associated with successful AR treatment.

Measurement of cf-DNA has recently been started for kidney transplant recipients. There will be two groups of patients eligible for this study:

1. those who have had sequential measurement of cf-DNA prior to graft dysfunction leading to a biopsy, and
2. those who have not had previous measurement of cf-DNA

Conditions

  • Kidney Transplant Failure and Rejection
  • Kidney Transplant; Complications
  • Kidney Transplant Rejection
  • Transplant; Complication, Rejection
  • Transplant Dysfunction

Interventions

GENETIC

cf-DNA Collection

For all consenting recipients undergoing kidney biopsy between 1 and 12 months post-transplant, a single tube of blood will be drawn (at the time of other blood draws so that there is no additional needle stick) to measure cf-DNA. The tube will be shipped to the California lab for determination of donor cf-DNA. For recipients whose biopsy shows AR, a tube of blood will be drawn at 2, 4, 6, and 8 weeks after initiation of anti-rejection treatment and similarly will be shipped to the California lab for determination of cf-DNA. Recipients whose exit biopsy shows ongoing inflammation and receiving additional anti-rejection therapy will have an additional exit biopsy additional cf-DNA determinations.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2023-09-05
Completion
2023-09-05

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04019353 on ClinicalTrials.gov