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Deceased Donor Biomarkers and Recipient Outcomes (DDS)

8 april 2020 bijgewerkt door: Yale University

Deceased Donor Urinary Biomarkers to Predict Kidney Transplant Outcomes

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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

Studietype

Observationeel

Inschrijving (Werkelijk)

1679

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06510
        • Yale New Haven Hospital
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Waltham, Massachusetts, Verenigde Staten, 02451
        • New England Organ Bank
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48108
        • Gift of Life Michigan
      • Detroit, Michigan, Verenigde Staten, 48201
        • Harper University Hospital
    • New Jersey
      • Livingston, New Jersey, Verenigde Staten, 07039
        • St. Barnabas Medical Center
      • New Providence, New Jersey, Verenigde Staten, 07974
        • New Jersey Sharing Network
      • Newark, New Jersey, Verenigde Staten, 07112
        • Newark Beth Israel Medical Center
    • New York
      • New York, New York, Verenigde Staten, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Verenigde Staten, 10467
        • Montefiore Medical Center
      • New York, New York, Verenigde Staten, 10001
        • New York Organ Donor Network
      • New York, New York, Verenigde Staten, 10032
        • NewYork-Presbyterian/ Columbia University Irving Medical Center
      • New York, New York, Verenigde Staten, 10065
        • The New York Hospital (Cornell)
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Verenigde Staten, 19102
        • Hahnemann University Hospital
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Gift of Life Donor Program- Philadelphia

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Delayed Graft Function
Tijdsspanne: Assessed within first week of receiving renal transplant
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)
Tijdsspanne: median of 4 years of follow-up
Requirement of chronic dialysis or retransplantation after renal transplant.
median of 4 years of follow-up

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Graft Function (detailed cohort)
Tijdsspanne: median of 4 years of follow-up
Serum creatinine and estimated glomerular filtration rate at specified time points over a five year period.
median of 4 years of follow-up

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Yale University

Medewerkers

Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Onderzoekers

  • Hoofdonderzoeker: Chirag R Parikh, MD PhD, Yale University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2010

Primaire voltooiing (Werkelijk)

1 december 2019

Studie voltooiing (Werkelijk)

1 maart 2020

Studieregistratiedata

Eerst ingediend

30 april 2013

Eerst ingediend dat voldeed aan de QC-criteria

2 mei 2013

Eerst geplaatst (Schatting)

7 mei 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 april 2020

Laatste update ingediend die voldeed aan QC-criteria

8 april 2020

Laatst geverifieerd

1 april 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1206010465
  • R01DK093770-01A1 (Subsidie/contract van de Amerikaanse NIH)

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