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Deceased Donor Kidney Transplant | Deceased Donor Biomarkers and Recipient Outcomes

Deceased Donor Kidney Transplant research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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 Exclusion Criteria: • Donor Cohort: Lack of adequate biospecimen quantity or quality as per protocol

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Deceased Donor Kidney Transplant

Acute Kidney Injury

Delayed Graft Function

End Stage Renal Disease

Graft Failure

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Deceased-Donor CohortWe will collect urine samples from approximately 1600 deceased donors and approximately 600 perfusate samples from machine-pumped kidneys from participating organ procurement organizations (OPOs).

Recipient Cohort (Overall and Detailed)No samples will be collected from the recipients. Only clinical data and outcomes will be collected from the recipients.

Study Status

Active, not recruiting

Start Date: May 2010

Completed Date: December 2018

Phase: N/A

Type: Observational

Design:

Primary Outcome: Delayed Graft Function

Secondary Outcome: Graft Function (detailed cohort)

Study sponsors, principal investigator, and references

Principal Investigator: Chirag R Parikh, MD PhD

Lead Sponsor: Yale University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01848249

Hall IE, Bhangoo RS, Reese PP, Doshi MD, Weng FL, Hong K, Lin H, Han G, Hasz RD, Goldstein MJ, Schröppel B, Parikh CR. Glutathione S-transferase iso-enzymes in perfusate from pumped kidneys are associated with delayed graft function. Am J Transplant. 2014 Apr;14(4):886-96. doi: 10.1111/ajt.12635. Epub 2014 Feb 24.

Hall IE, Reese PP, Weng FL, Schröppel B, Doshi MD, Hasz RD, Reitsma W, Goldstein MJ, Hong K, Parikh CR. Preimplant histologic acute tubular necrosis and allograft outcomes. Clin J Am Soc Nephrol. 2014 Mar;9(3):573-82. doi: 10.2215/CJN.08270813. Epub 2014 Feb 20.

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