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NCT04019353 · ClinicalTrials.gov registry record
Cf-DNA Assay During Treatment of Acute Rejection
A clinical trial, sponsored by University of Minnesota.
- Completed
- Registry status
- 15
- Enrollment target
NCT04019353: Completed study, sponsored by University of Minnesota.
NCT04019353 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04019353 has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- GENETIC cf-DNA Collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2023-09-05 |
What the finished NCT04019353 record still lists
NCT04019353 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which cf-DNA Collection is the first listed.
NCT04019353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04019353 about?
NCT04019353 is a clinical study titled "Cf-DNA Assay During Treatment of Acute Rejection". 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 ...
What is the current status of trial NCT04019353?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2019-06-01. Estimated completion is 2023-09-05.
What interventions are being tested in trial NCT04019353?
The interventions under investigation include: cf-DNA Collection (GENETIC).
Who is sponsoring clinical trial NCT04019353?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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