Clinical trial

Cf-DNA Assay During Treatment of Acute Rejection-Pilot Study

NCT04019353

Name

SURG-2018-27247

Description

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

Trial arms

Trial start

2019-06-01

Estimated PCD

2023-09-05

Trial end

2023-09-05

Status

Completed

Treatment

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.

Arms:

cf-DNA Collection

Size

Primary endpoint

Number of participants converted to <1% measured donor cf-DNA concentrations

8 weeks

Number of participants who achieve 61% reduction in measured donor cf-DNA concentrations

8 weeks

Eligibility criteria

Inclusion Criteria: * Adult kidney transplant recipients undergoing transplant biopsy between 1 and 12 months post-transplant because of graft dysfunction. Exclusion Criteria: * \<1 months post-transplant * \>12 months post-transplant

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'cell-free DNA'}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

Updated at

2024-03-13

1 organization

1 product

6 indications

Organization

University of Minnesota

Product

cf-DNA

Indication

Kidney Transplant Failure and Rejection

Indication