Cf-DNA Assay During Treatment of Acute Rejection
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|ClinicalTrials.gov Identifier: NCT04019353|
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : February 15, 2023
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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:
- those who have had sequential measurement of cf-DNA prior to graft dysfunction leading to a biopsy, and
- 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|
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Cf-DNA Assay During Treatment of Acute Rejection-Pilot Study|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||January 31, 2024|
|Estimated Study Completion Date :||February 28, 2024|
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.
- 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.
- 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%.
- 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
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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|
- Adult kidney transplant recipients undergoing transplant biopsy between 1 and 12 months post-transplant because of graft dysfunction.
- <1 months post-transplant
- >12 months post-transplant
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
|Contact: Arthur Matas, MDemail@example.com|
|Contact: Mary Farnsworthfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Arthur Matas, MD 612-625-5151 email@example.com|
|Responsible Party:||University of Minnesota|
|Other Study ID Numbers:||
|First Posted:||July 15, 2019 Key Record Dates|
|Last Update Posted:||February 15, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|