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Deceased Donor Biomarkers and Recipient Outcomes (DDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01848249
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : April 9, 2020
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Johns Hopkins University
Information provided by (Responsible Party):
Yale University

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.

Condition or disease
Deceased Donor Kidney Transplant Acute Kidney Injury Delayed Graft Function End Stage Renal Disease Graft Failure

Detailed Description:

Our study has several key processes that we have developed and tested to address our scientific aims:

  1. Enrollment

    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). We estimate that our final donor group will be comprised of 55% standard criteria donors, 25% expanded-criteria donors and 10% donors after cardiac death. Approximately, 20% of the kidneys will be discarded.

  2. Donor Data

    Donor variables come from two sources: the United Network for Organ Sharing (UNOS) database and detailed data abstraction from each OPO. The UNOS database provides data on all donors with demographics and other important clinical characteristics. The additional data collected by the OPO staff captures granular information on events surrounding donor death, which are not included in the UNOS database. These data will be available on all enrolled donors and include variables such as serial serum creatinine, nadir blood pressures, medication and vasopressor use, and machine pump parameters.

  3. Overall Recipient Cohort

    Over 2000 recipients will have received kidneys from the deceased donors in our study. The Overall Cohort will comprise all of these recipients General demographic and clinical characteristics about recipients in the Overall Cohort will come from the UNOS database. For the Overall Recipient Cohort, we will ascertain delayed graft function (DGF) through center reports to UNOS. We will ascertain allograft failure through center reports to UNOS and new episodes of wait-listing and re-transplant collected by UNOS, Recipient mortality will be ascertained through the center reports to UNOS/SRTR and through the Social Security Death Master File.

  4. Detailed Recipient Cohort

    A subset of over 1100 recipients of the Overall Cohort who had transplantation at any of our collaborating transplant centers will comprise this cohort. For the Detailed Subcohort, on-site coordinators will perform manual chart review and abstract more extensive data about each recipient including dialysis indications post-transplant, comorbidities, and specific doses of immunosuppression. For the Detailed Subcohort, we will also collect data on clinical events for up to five years after transplantation, including acute rejection and estimated glomerular filtration rate at the time of transplantation and at months 1, 3, 6, 12, 18, 24, 30, 36, 48 and 60 months after transplant.

  5. Novel biomarkers will be measured in urine and perfusate

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Study Type : Observational
Actual Enrollment : 1679 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Deceased Donor Urinary Biomarkers to Predict Kidney Transplant Outcomes
Study Start Date : May 1, 2010
Actual Primary Completion Date : December 2019
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Delayed Graft Function [ Time Frame: Assessed within first week of receiving renal transplant ]
    Receipt of dialysis within the first seven days post renal transplant

  2. Death-Censored Graft Failure (Overall Cohort) [ Time Frame: median of 4 years of follow-up ]
    Requirement of chronic dialysis or retransplantation after renal transplant.

Secondary Outcome Measures :
  1. Graft Function (detailed cohort) [ Time Frame: median of 4 years of follow-up ]
    Serum creatinine and estimated glomerular filtration rate at specified time points over a five year period.

Biospecimen Retention:   Samples Without DNA
((A)) Urine Samples: At time of deceased donor nephrectomy ((B)) Perfusates: At time of initiation and stopping of machine perfusion

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01848249

Show Show 17 study locations
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Johns Hopkins University
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Principal Investigator: Chirag R Parikh, MD PhD Yale University
Additional Information:
Publications of Results:
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Responsible Party: Yale University Identifier: NCT01848249    
Other Study ID Numbers: 1206010465
R01DK093770-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Keywords provided by Yale University:
deceased donors
kidney donor
transplant recipients
kidney transplant
delayed graft function
end stage renal disease
graft failure
Additional relevant MeSH terms:
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Acute Kidney Injury
Kidney Diseases
Kidney Failure, Chronic
Delayed Graft Function
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Pathologic Processes