Deceased Donor Biomarkers and Recipient Outcomes

Completed

Conditions studied: Deceased Donor Kidney Transplant, Acute Kidney Injury, Delayed Graft Function, End Stage Renal Disease, Graft Failure

In brief

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.

Key facts

Study ID

NCT01848249

Run by

Yale University

People needed

1679

Starts

2010-05-01

Expected to finish

2020-03-01

Last updated by the study team

2020-04-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Donor Cohort: Appropriate informed consent for research according to OPO policies
• Recipient Cohorts: Any recipient of at least one kidney from a deceased donor enrolled by our participating OPOs

You may not qualify if…

• Donor Cohort: Lack of adequate biospecimen quantity or quality as per protocol

Where it is running

• 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
• New York Organ Donor Network — New York, New York, United States
• Mount Sinai School of Medicine — 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
• Montefiore Medical Center — New York, New York, United States
• Hahnemann University Hospital — Philadelphia, Pennsylvania, United States
• Gift of Life Donor Program- Philadelphia — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.