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Deceased Donor Biomarkers and Recipient Outcomes (DDS)

2020年4月8日更新者：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.

調査の概要

状態

完了

条件

詳細な説明

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

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.
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.
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.
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.
Novel biomarkers will be measured in urine and perfusate

研究の種類

観察的

入学 (実際)

1679

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

子
大人
高齢者

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

観測モデル：コホート
時間の展望：見込みのある

グループ/コホートの数

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Delayed Graft Function 時間枠：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) 時間枠：median of 4 years of follow-up	Requirement of chronic dialysis or retransplantation after renal transplant.	median of 4 years of follow-up

二次結果の測定

結果測定	メジャーの説明	時間枠
Graft Function (detailed cohort) 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Yale University

協力者

Johns Hopkins University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

捜査官

主任研究者：Chirag R Parikh, MD PhD、Yale University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

Pubmed Link for Deceased Donor Study

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2010年5月1日

一次修了 (実際)

2019年12月1日

研究の完了 (実際)

2020年3月1日

試験登録日

最初に提出

2013年4月30日

QC基準を満たした最初の提出物

2013年5月2日

最初の投稿 (見積もり)

2013年5月7日

学習記録の更新

投稿された最後の更新 (実際)

2020年4月9日

QC基準を満たした最後の更新が送信されました

2020年4月8日

最終確認日

2020年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

1206010465
R01DK093770-01A1 (米国 NIH グラント/契約)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。