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Deceased Donor Biomarkers and Recipient Outcomes (DDS)

8 aprile 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1679

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Delayed Graft Function
Lasso di tempo: 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)
Lasso di tempo: median of 4 years of follow-up
Requirement of chronic dialysis or retransplantation after renal transplant.
median of 4 years of follow-up

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Graft Function (detailed cohort)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Yale University

Collaboratori

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

Investigatori

  • Investigatore principale: Chirag R Parikh, MD PhD, Yale University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2010

Completamento primario (Effettivo)

1 dicembre 2019

Completamento dello studio (Effettivo)

1 marzo 2020

Date di iscrizione allo studio

Primo inviato

30 aprile 2013

Primo inviato che soddisfa i criteri di controllo qualità

2 maggio 2013

Primo Inserito (Stima)

7 maggio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 aprile 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 aprile 2020

Ultimo verificato

1 aprile 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1206010465
  • R01DK093770-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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