Deceased Donor Biomarkers and Recipient Outcomes
Public ClinicalTrials.gov record NCT01848249. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Deceased Donor Urinary Biomarkers to Predict Kidney Transplant Outcomes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01848249
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,679 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2010
- Primary completion
- Nov 30, 2019
- Completion
- Feb 29, 2020
- Last update posted
- Apr 8, 2020
2010 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| New England Organ Bank | Waltham | Massachusetts | 02451 | — |
| Gift of Life Michigan | Ann Arbor | Michigan | 48108 | — |
| Harper University Hospital | Detroit | Michigan | 48201 | — |
| St. Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| New Jersey Sharing Network | New Providence | New Jersey | 07974 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| New York Organ Donor Network | New York | New York | 10001 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| NewYork-Presbyterian/ Columbia University Irving Medical Center | New York | New York | 10032 | — |
| The New York Hospital (Cornell) | New York | New York | 10065 | — |
| Montefiore Medical Center | New York | New York | 10467 | — |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | — |
| Gift of Life Donor Program- Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01848249, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2020 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01848249 live on ClinicalTrials.gov.