Deceased Donor Biomarkers and Recipient Outcomes
DDS
Deceased Donor Urinary Biomarkers to Predict Kidney Transplant Outcomes
2 other identifiers
observational
1,679
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2010
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 30, 2013
CompletedFirst Posted
Study publicly available on registry
May 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedApril 9, 2020
April 1, 2020
9.6 years
April 30, 2013
April 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Delayed Graft Function
Receipt of dialysis within the first seven days post renal transplant
Assessed within first week of receiving renal transplant
Death-Censored Graft Failure (Overall Cohort)
Requirement of chronic dialysis or retransplantation after renal transplant.
median of 4 years of follow-up
Secondary Outcomes (1)
Graft Function (detailed cohort)
median of 4 years of follow-up
Study Arms (2)
Deceased-Donor Cohort
We 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.
Eligibility Criteria
The population from which our Deceased-Donor Cohort will be selected is all potential deceased organ donors located in the regions serviced by our participating organ procurement organizations (OPOs). The recipient cohorts will be defined by the deceased donors enrolled in the study, and thus, the study population for this group is all recipients of kidneys from deceased organ donors procured in the regions serviced by our participating OPOs.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- Johns Hopkins Universitycollaborator
Study Sites (17)
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
New England Organ Bank
Waltham, Massachusetts, 02451, United States
Gift of Life Michigan
Ann Arbor, Michigan, 48108, United States
Harper University Hospital
Detroit, Michigan, 48201, United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039, United States
New Jersey Sharing Network
New Providence, New Jersey, 07974, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
New York Organ Donor Network
New York, New York, 10001, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
NewYork-Presbyterian/ Columbia University Irving Medical Center
New York, New York, 10032, United States
The New York Hospital (Cornell)
New York, New York, 10065, United States
Montefiore Medical Center
New York, New York, 10467, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102, United States
Gift of Life Donor Program- Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Related Publications (5)
Hall IE, Bhangoo RS, Reese PP, Doshi MD, Weng FL, Hong K, Lin H, Han G, Hasz RD, Goldstein MJ, Schroppel 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.
PMID: 24612768RESULTHall IE, Reese PP, Weng FL, Schroppel 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.
PMID: 24558049RESULTLiu C, Hall IE, Mansour S, Thiessen Philbrook HR, Jia Y, Parikh CR. Association of Deceased Donor Acute Kidney Injury With Recipient Graft Survival. JAMA Netw Open. 2020 Jan 3;3(1):e1918634. doi: 10.1001/jamanetworkopen.2019.18634.
PMID: 31913491RESULTPuthumana J, Hall IE, Reese PP, Schroppel B, Weng FL, Thiessen-Philbrook H, Doshi MD, Rao V, Lee CG, Elias JA, Cantley LG, Parikh CR. YKL-40 Associates with Renal Recovery in Deceased Donor Kidney Transplantation. J Am Soc Nephrol. 2017 Feb;28(2):661-670. doi: 10.1681/ASN.2016010091. Epub 2016 Jul 22.
PMID: 27451287RESULTYaffe HC, von Ahrens D, Urioste A, Mas VR, Akalin E. Impact of Deceased-donor Acute Kidney Injury on Kidney Transplantation. Transplantation. 2024 Jun 1;108(6):1283-1295. doi: 10.1097/TP.0000000000004848. Epub 2023 Nov 22.
PMID: 37990359DERIVED
Related Links
Biospecimen
((A)) Urine Samples: At time of deceased donor nephrectomy ((B)) Perfusates: At time of initiation and stopping of machine perfusion
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chirag R Parikh, MD PhD
Yale University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2013
First Posted
May 7, 2013
Study Start
May 1, 2010
Primary Completion
December 1, 2019
Study Completion
March 1, 2020
Last Updated
April 9, 2020
Record last verified: 2020-04