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NCT01848249 · ClinicalTrials.gov registry record
Deceased Donor Biomarkers and Recipient Outcomes
A clinical trial, sponsored by Yale University.
- Completed
- Registry status
- 1,679
- Enrollment target
NCT01848249: Completed study, sponsored by Yale University.
NCT01848249 is a clinical trial that has completed, run by Yale University. The registered enrollment target is 1,679 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01848249 has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- 1,679 participants
- Enrollment target
Study Summary
Compared to chronic dialysis, kidney transplantation provides recipients with longer survival and better quality of life at a lower cost. In order to meet increasing demands for kidney allografts, kidneys from older and sicker donors are being procured. This has led to greater discard rates of donated kidneys as well as more complications for recipients, including shorter allograft survival. Available clinical models to predict kidney allograft quality have poor prognostic ability and do not asses the degree of kidney allograft injury. However, allograft injury near the time of procurement can lead to major consequences for the transplant recipient: greater risks of delayed graft function, poor allograft function and premature loss of the transplant. Our proposal is based on the hypotheses that novel biomarkers measured in donor urine and transport media at the time of procurement can assess acute and chronic kidney injury and that distinct biomarker patterns will predict allograft survival. In collaboration with five organ procurement organizations, we will collect urine samples from consecutive deceased donors and samples of transport solution for every pumped kidney. We will measure markers of injury, repair, inflammation and fibrosis. We will determine mortality and allograft survival in all patients by linkage to the United Network for Organ Sharing (UNOS) database (Overall Cohort). Additionally, we will perform a detailed chart review of a subset of recipients (detailed cohort) and will also examine associations between biomarkers and longitudinal graft function over five years after transplant. Early, non-invasive and rapid assessment of donor kidney injury could drive better allocation decisions and potentially reduce the rates of post-transplant complications. Further, these new tools could provide a platform for clinical trials of therapies for allografts and kidney transplant recipients aimed at ameliorating allograft injury.
Primary Outcome
Receipt of dialysis within the first seven days post renal transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,679 participants |
| Start Date | 2010-05-01 |
| Est. Completion | 2020-03 |
What the finished NCT01848249 record still lists
NCT01848249 is an observational study that tracks outcomes without assigning an intervention. Its 1,679 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01848249 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01848249 about?
NCT01848249 is a clinical study titled "Deceased Donor Biomarkers and Recipient Outcomes". Compared to chronic dialysis, kidney transplantation provides recipients with longer survival and better quality of life at a lower cost. In order to meet increasing demands for kidney allografts, kidneys from older and sicker donors are being procured. This has led to greater discard rates of donat...
What is the current status of trial NCT01848249?
This trial is currently completed. The enrollment target is 1,679 participants. The study started on 2010-05-01. Estimated completion is 2020-03.
Who is sponsoring clinical trial NCT01848249?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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