FindMyKOL
Clinical trialNCT01848249CompletedObservational

Deceased Donor Biomarkers and Recipient Outcomes

SponsorYale UniversityEnrollment1,679Acute Kidney InjuryDeceased Donor Kidney TransplantDelayed Graft FunctionEnd Stage Renal DiseaseGraft Failure
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Yale New Haven Hospital

    New Haven, Connecticut, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, United States

  • New England Organ Bank

    Waltham, Massachusetts, United States

  • Gift of Life Michigan

    Ann Arbor, Michigan, United States

  • Harper University Hospital

    Detroit, Michigan, United States

  • St. Barnabas Medical Center

    Livingston, New Jersey, United States

  • New Jersey Sharing Network

    New Providence, New Jersey, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, United States

  • Montefiore Medical Center

    New York, New York, United States

  • Mount Sinai School of Medicine

    New York, New York, United States

  • New York Organ Donor Network

    New York, New York, United States

  • Newyork-Presbyterian/ Columbia University Irving Medical Center

    New York, New York, United States

  • the New York Hospital (cornell)

    New York, New York, United States

  • Gift of Life Donor Program- Philadelphia

    Philadelphia, Pennsylvania, United States

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 May 2010
Primary completion
31 Dec 2019
Completion
31 Mar 2020
Last update posted
9 Apr 2020
Registered enrollment
1,679
Registry id
NCT01848249

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.