Cf-DNA Assay During Treatment of Acute Rejection

NCT04019353 | Completed

• 1 other identifier: SURG-2018-27247
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 1.those who have had sequential measurement of cf-DNA prior to graft dysfunction leading to a biopsy, and
2. 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

Outcome Measures

Primary Outcomes (2)

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

  Number of patients with donor cf-DNA \>1% who achieve an intra-patient change of measured donor cf-DNA to less than 1% from the time of kidney biopsy for AR to 6 weeks after initiation of treatment.

  8 weeks

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

  Number of patients who do not have \> 1% donor cf-DNA at the time of rejection who achieve a reduction in donor cf-DNA by 61%.

  8 weeks

Secondary Outcomes (1)

• Number of participants who return to baseline measured donor cf-DNA concentrations

  8 weeks

Study Arms (1)

cf-DNA Collection

All patients undergoing kidney allograft biopsy for suspicion of an acute rejection episode will be approached for consent into the study. Patients who consent to the study will have the cf-DNA test drawn at time of biopsy to determine levels of cf-DNA. All consented patients will be followed for biopsy outcomes. Those whose biopsy shows acute rejection leading to treatment will have cf-DNA determination at 2, 4, 6, and 8 weeks post biopsy. Recipients with persistent high cf-DNA levels will undergo repeat biopsy at \~6 weeks after end of treatment per standard of care (this is not performed for purpose of the study, but for clinical care).

Genetic: cf-DNA Collection

Interventions

cf-DNA Collection GENETIC

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.

cf-DNA Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult kidney transplant recipients undergoing transplant biopsy between 1 and 12 months post-transplant because of graft dysfunction.

You may qualify if:

• Adult kidney transplant recipients undergoing transplant biopsy between 1 and 12 months post-transplant because of graft dysfunction.

You may not qualify if:

• \<1 months post-transplant
• \>12 months post-transplant

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

cell-free DNA

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: July 15, 2019
• Study Start: June 1, 2019
• Primary Completion: September 5, 2023
• Study Completion: September 5, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)