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NCT04130685 · ClinicalTrials.gov registry record
Donor-Derived Cell-Free DNA for Surveillance in Simultaneous Pancreas and Kidney Transplant Recipients
A clinical trial, sponsored by Rush University Medical Center.
- Completed
- Registry status
- 48
- Enrollment target
NCT04130685 is a clinical trial that has completed, run by Rush University Medical Center. The registered enrollment target is 48 participants.
The verdict
NCT04130685 has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- 48 participants
- Enrollment target
Study Summary
The AlloSure test is approved by the Centers for Medicare \& Medicaid Services (CMS) for use in Medicare patients to assess the probability of allograft rejection in kidney transplant patients. The pivotal DART study discusses the use of the non-invasive AlloSure test to measure donor derived cell-free DNA (dd-cfDNA) and the Allosure test can by used to discriminate active rejection in renal transplant patients. Pancreas allograft rejection still remains a major clinical challenge and is a primary cause of death censored pancreas allograft loss. Pancreas transplant rejection is diagnosed by biopsy, however it is not commonly performed because of the complications such as pancreatic leak, graft loss and patient death. Currently at Rush surveillance biopsy of the pancreas are not performed routinely due to the above risks. At RUMC, patients are followed post-transplant with series of labs at set intervals that include lipase, DSA, C-Peptide, and GAD65 for surveillance of rejection The AlloSure test was introduced for routine use in kidney transplant recipients at Rush University Medical Center in October 2017, after CMS approval and then as part of the KOAR Study in May of 2018. AlloSure test has been included as part of the routine labs for surveillance of rejection in pancreas transplant recipients at RUMC since September 2018 after it was approved for compassionate use. The addition of AlloSure has helped to improve surveillance of rejection in pancreas transplant recipients and has reduced the need for the kidney biopsy as a surrogate marker of rejection in the pancreas. Our goal is to determine if AlloSure can be used for surveillance for rejection in recipients of Simultaneous Pancreas and Kidney (SPK) Transplant recipients.
Interventions
- DIAGNOSTIC_TEST Allosure Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2022-12-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04130685
The ClinicalTrials.gov registry entry for NCT04130685 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Allosure Test is the first listed.
NCT04130685 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04130685 about?
NCT04130685 is a clinical study titled "Donor-Derived Cell-Free DNA for Surveillance in Simultaneous Pancreas and Kidney Transplant Recipients". The AlloSure test is approved by the Centers for Medicare \& Medicaid Services (CMS) for use in Medicare patients to assess the probability of allograft rejection in kidney transplant patients. The pivotal DART study discusses the use of the non-invasive AlloSure test to measure donor derived cell-f...
What is the current status of trial NCT04130685?
This trial is currently completed. The enrollment target is 48 participants. The study started on 2020-01-15. Estimated completion is 2022-12-01.
What interventions are being tested in trial NCT04130685?
The interventions under investigation include: Allosure Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04130685?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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