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Cf-DNA Assay During Treatment of Acute Rejection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04019353
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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. 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

Condition or disease Intervention/treatment
Kidney Transplant Failure and Rejection Kidney Transplant; Complications Kidney Transplant Rejection Transplant; Complication, Rejection Transplant Dysfunction Genetic: cf-DNA Collection

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cf-DNA Assay During Treatment of Acute Rejection-Pilot Study
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Group/Cohort Intervention/treatment
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

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.





Primary Outcome Measures :
  1. Number of participants converted to <1% measured donor cf-DNA concentrations [ Time Frame: 8 weeks ]
    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.

  2. Number of participants who achieve 61% reduction in measured donor cf-DNA concentrations [ Time Frame: 8 weeks ]
    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%.


Secondary Outcome Measures :
  1. Number of participants who return to baseline measured donor cf-DNA concentrations [ Time Frame: 8 weeks ]
    Number of patients for whom a baseline of donor cf-DNA has been ascertained through monitoring prior to acute rejection and who return to baseline cf-DNA after treatment.


Biospecimen Retention:   Samples With DNA
cell-free DNA


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult kidney transplant recipients undergoing transplant biopsy between 1 and 12 months post-transplant because of graft dysfunction.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019353


Contacts
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Contact: Arthur Matas, MD 612-625-5151 matas001@umn.edu
Contact: Mary Farnsworth 612-624-9695 ewigx005@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Arthur Matas, MD    612-625-5151    matas001@umn.edu   
Sponsors and Collaborators
University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04019353    
Other Study ID Numbers: SURG-2018-27247
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No