CompletedNot Applicable

Cf-DNA Assay During Treatment of Acute Rejection

United States15 participantsStarted 2019-06-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 8 weeks

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

Timeframe: 8 weeks

Trial details

NCT IDNCT04019353

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-05

View on ClinicalTrials.gov More Kidney Transplant Failure and Rejection trials