Deceased-Donor Biomarker Study

Overview

The shortage of kidneys for transplantation is a major dilemma, which has driven efforts to expand the organ supply by using kidneys from deceased donors with risk factors for allograft dysfunction. Greater use of kidneys with uncertain quality and the lack of precise tools to measure kidney quality during procurement have led to high organ discard rates and increasing numbers of transplant recipients with allograft dysfunction. Without precise methods to assess kidney quality, it is likely that some useful kidneys are discarded and some low-quality kidneys are transplanted with potentially harmful results. This project both directly addresses these problems and advances the goals of a recent FDA conference statement by studying biomarkers of ischemia-reperfusion injury in kidney transplant and their associations with allograft outcomes.

This biomarker study is one of the largest applied translational research studies in kidney transplantation. In collaboration with several organ procurement organizations, we are collecting urine from 1,679 deceased donors at the time of procurement along with samples of transport solution for every pumped kidney. We have begun to measure known injury biomarkers including IL-18, NGAL, KIM-1, LFABP, and cystatin C, with further plans to measure biomarkers of chronic kidney disease, such as uromodulin, albumin, and TGF-ß. We are evaluating rates of delayed graft function and allograft failure in recipients of these kidneys by linkage to the United Network for Organ Sharing database. 

We are also collecting detailed recipient data about estimated glomerular filtration rate, immunosuppression, acute rejection, and other complications for two years after transplant via chart review at several participating transplant centers. Our ultimate goals are to help maximize the allocation of viable kidneys, develop therapies for ischemia-reperfusion injury, and improve recipient outcomes through the study of noninvasive deceased-donor biomarkers at the time of procurement.

Bio Profile

Chirag R Parikh, MD, PhD, FACP

Principal Investigator

Professor of Medicine (Nephrology)

Director, Program of Applied Translational Research

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Bio Profile

Haiqun Lin, MD, PhD

Associate Professor of Biostatistics

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Isaac E. Hall, MD, MS 

University of Utah

Peter Reese, MD, MSCE 

University of Pennsylvania

Bernd Schroppel, MD 

University of Ulm

Barbara Murphy, MD 

Mount Sinai Hospital

Mona D. Doshi, MD

Harper University Hospital

Francis L. Weng, MD, MSCE

Saint Barnabas Health


Organ Procurement Organizations:

Alexandra K. Glazier

New England Organ Bank

Joseph S. Roth

New Jersey Sharing Network

Helen Irving

LiveOnNY

Rick Hillbom

Gift of Life Michigan

Richard D. Hasz 

Gift of Life Donor Program

Publications

Contact Information

For more information, or if you are interested in collaborating on this study, please contact PATR@yale.edu

Project Funding

Funding for this project comes, in part, from the following grants:

RO1DK093770 (NIH-NIDDK)
“Novel Kidney Injury Tools in Deceased Organ Donation to Predict Graft Outcome”

ROTRF #261612977
(Roche Organ Transplantation Research Fund)
“Impact of Donor Kidney Function and Injury on Kidney Transplant Recipient Allograft Function”